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‘Battle of the Forms': Can it be won? 09/18/2014

Posted by Morse, Barnes-Brown Pendleton in Licensing & Strategic Alliances, New Resources.
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By: Michael J. Cavaretta

cavaretta2Often, in transactions between customers and vendors, each party has its own “boilerplate” terms and conditions that it wants to use, which of course are often quite different than the other party’s terms – a scenario referred to as “the battle of the forms”. So how does one know which terms govern the transaction? This presentation helps to sort it out.

Originally presented on 9/17/14, MBBP IP & Licensing attorney Mike Cavaretta touches upon the following:

  • Sale of services vs. sale of goods
  • Is software a service or good?
  • Is a software license a sale of software?
  • Electronic agreements
  • Strategies

View the slides here. Questions? Contact Mike.

Upcoming Retrogression for Indian EB-2 Immigrant Visas 09/16/2014

Posted by Morse, Barnes-Brown Pendleton in Immigration, Legal Developments.
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After months of steadily moving forward the priority date for the Employment-based Second preference category (“EB-2”) for foreign nationals chargeable to India, in the October 2014 Visa Bulletin the Department of State (“DOS”) has stated that the EB-2 India priority date will retrogress to 2005 as early as on November 1, 2014.  Any Indian national with a “current” priority date for the EB-2 category is therefore encouraged to immediately file their I-485 Adjustment of Status application.

Additionally, officials within the DOS have told the American Immigration Lawyers Association (“AILA”) that the maximum number of Indian EB-2 immigrant visas for the current government fiscal year (running to September 30, 2014) has been reached.  Therefore, the DOS will not be allocating any new immigrant visas for EB-2 Indian nationals until October 1, 2014, which is the start of the next government fiscal year.  However, the Citizenship and Immigration Services (“CIS”) has stated that it will continue to accept filings with a current priority date – presumably through the end of October.   In addition, pending I-485 Adjustment of Status application and new applications filed during the month of September will be held until October 1, 2014, at which time they will begin to be processed.  As a result, Indian nationals should not delay their filing due to the unavailability of Immigrant Visas.

What this all means for the next 6 weeks is not clear.  There are a number of pending I-485 Adjustment of Status applications filed by Indian nationals with current priority dates.  We expect that some number of these pending cases will be approved when visa numbers again become available for a short period of time on October 1st.  How many will be processed and approved within this short window of time cannot now be determined.

Feel free to contact any member of our Immigration Law Group with any questions.

Going Concern Evaluation – FASB Issues a Roadmap for Management 09/15/2014

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Public Companies.
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Corporate Attorney Daniele Ouellette Levy

By: Daniele Ouellette Levy

Under US GAAP (generally accepted accounting principles) a company’s continuation as a going concern is presumed when preparing the financial statements.  As part of their review of the financial statements, auditors are required to evaluate whether there is a substantial doubt about the company’s ability to continue as a going concern for a reasonable period of time (often 12 months) after the date of the financial statements.

Until recently GAAP did not provide guidance to management regarding management’s responsibility to evaluate whether there exists a substantial doubt about the company’s ability to continue as a going concern.  As a result, there have been significant inconsistencies between companies in their evaluation of this issue as well as the related disclosures.  Also, without the benefit of guidance, management was often left to rely on the assessment performed by the auditors.

Companies may face unintended negative implications on their business resulting from the auditor’s determination of “substantial doubt” and the inclusion of a going concern qualification in the audit letter. For example, inclusion of a going concern qualification may result in a significant reduction in a company’s D&B Supplier Evaluation Risk Rating (SER).  The SER, which predicts the likelihood that a business will seek legal relief from creditors or cease operations in the next 12 months, is relied on by many large retailers to evaluate their vendors.  A significant reduction in a company’s SER could result in that company being dropped from the approved vendor list and losing a significant customer.

In August, FASB issued guidance to management in making this evaluation.  Based on this guidance, management is required to evaluate on a quarterly basis whether there are conditions or events that raise substantial doubt about the company’s ability to continue as a going concern in the next 12 months.  In its guidance FASB defined substantial doubt as: “Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued . . . .”

Careful review of the roadmap provided by FASB and analysis by management may help standardize the evaluation and disclosures provided by companies and avoid negative business implications associated with a going concern qualification.

For more information on this topic, please contact Daniele.

FDA Establishes “Purple Book” for Biosimilars 09/15/2014

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.
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By: David Fazzolare and Joanna Brougher

Patent Attorney David FazzolareOn September 9, 2014, the FDA announced the establishment of the “Purple Book” (formally entitled “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”), which is the equivalent for biologics of the FDA’s “Orange Book.” Whereas the Orange Book lists all small molecule reference listed drugs and their counterpart generic drugs that have been approved by the FDA under the Hatch-Waxman Act, the Purple Book Patent Attorney Joanna Brougherlists all licensed biologics and will list the corresponding biosimilars when they are licensed by the FDA, and will designate whether the biosimilars are also interchangeable, under the Public Health Service Act (“PHSA”). The Purple Book will also provide the dates that the biologics were first licensed under section 351(a) of the PHSA, including whether the FDA has evaluated the biologic product for reference product exclusivity under section 351(k)(7) of the PHSA. Unlike the Orange Book, however, the Purple Book will not list patent information pertaining to licensed biologics.

Questions on the “Purple Book” can be directed to David or Joanna.

Mergers & Acquisitions 101 with Mark Tarallo 09/15/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, M&A, MBBP news.
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Attorney Mark Tarallo will present the basics of an M&A transaction from start to finish in tomorrow’s Mergers & Acquisitions 101 provided by MyLawCLE.

Key topics to be discussed:

  • Pre-Transaction Considerations
  • Basic Transaction Structuring-Tax, Liability Protection and Other Considerations
  • Transaction Documentation
  • Post-Closing Matters
  • Recent Delaware Case Law
  • Ethical Issues

This CLE program is available in multiple formats, including live and self-study versions. Live broadcast will take place on Tuesday, September 16th from 2:00 – 5:15 EST.

Register at MyLawCLE.

Anti-Retaliation Provision of Whistleblower Statute Does Not Apply Extraterritorially 09/12/2014

Posted by Morse, Barnes-Brown Pendleton in Public Companies.
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Corporate Attorney Joseph MarrowBy: Joe Marrow

On August 14, 2014, the Second Circuit Court of Appeals held that the anti-retaliation provision of the Dodd-Frank whistleblower statute does not apply extraterritorially.  In its decision, Liu v. Siemens A.G., No. 13-4385-cv (2d Cir. Aug. 14, 2014), the Second Circuit upheld the Federal District Court’s holding that a foreign employee cannot successfully bring an action under the anti-retaliation provision of the Dodd-Frank whistleblower statute alleging improper conduct for events taking place outside the United States.

In Liu v. Siemens, Liu, a former employee of Siemens, alleged that Siemens fired him in response to his report of improper conduct against Siemens and in so doing Siemens violated 15 U.S.C. Section 78u-6(h) of the Dodd-Frank Act which prohibits an employer from retaliating against an employee for making certain protected statements.  Most notably, Liu, who is not a U.S. citizen and was employed abroad by Siemens, alleged that all improper conduct occurred outside the United States.  The Second Circuit noted the presumption that legislation is intended to apply domestically absent clear congressional intent that the legislation was intended to apply extraterritorially.  The Court found no such congressional intent.  Absent any type of nexus between the improper conduct and the United States and the presumption against applying the statute outside the United States, the Court refused to apply the anti-retaliation provision against Siemens in this case.

The Second Circuit’s holding provides some assurance to foreign companies that if the conduct alleged to violate the anti-retaliation provisions of the Dodd-Frank whistleblower statute takes place outside the United States, the foreign corporation should not face exposure under the statute.

For more information on this topic, please contact Joe Marrow

MBBP Attorney Stanley Chalvire to Speak at MDG Boston Forum 09/05/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Events, MBBP news, Licensing & Strategic Alliances, Intellectual Property, Medical Devices, Internet and E-Commerce.
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chalvireMedical Development Group (MDG), an organization for professionals in the medical device industry, is hosting an upcoming forum event entitled “Intellectual Property Approaches to Safeguard Value”. MBBP IP and Licensing Attorney Stanley F. Chalvire will serve as one of the speakers of this forum event, which will generally be directed to intellectual property strategies for creating and preserving value of medical devices.

 During the forum, some topics that Stan will address include:

  • Trade Secrets and the protections they can provide
  • Distinguish Trade Secrets and Patents
  • Discuss Strategic Considerations to Maintain Trade Secrets

The event takes place at Constant Contact headquarters in Waltham, MA on Wednesday October 1st.

 To register, please visit MDG Boston 

 

MBBP Client Hastings Equity Partners Completes Sale of Advanced Precision Products, Inc. 09/04/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, MBBP news, Public Companies, Intellectual Property, Manufacturing, Retail & Service.
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Hastings Equity Partners, LLCMBBP client Hastings Equity Partners recently announced the sale of Advanced Precision Products, Inc. (APP) to Precision Engineered Products, LLC (PEP). Advanced Precision Products is a leading manufacturer of highly engineered components and products for oil & gas, medical, aerospace, automotive, military and commercial OEMs.  Morse, Barnes-Brown & Pendleton serves as counsel to Hastings Equity Partners, and advised it in connection with the structuring, negotiation and documentation of this transaction. Shannon Zollo was the lead corporate attorney on MBBP’s team, which also included attorneys Mark Tarallo and Jonathan Calla.

Hastings Equity Partners is a Waltham, MA-based, private investment firm that acquires and grows small to mid-sized enterprises.

Please visit Hastings Equity Partners for more information.

MBBP’s Joanna Brougher 2014 National Law Journal Rising Star 09/02/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Intellectual Property, Life Sciences, MBBP news, Medical Devices.
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9-2-2014 10-08-43 AM MBBP’s Joanna Brougher was selected for the 2014 National Law Journal’s list of Boston’s Rising Stars. The National Law Journal Rising Stars program recognizes the region’s 40 most promising lawyers age 40 and under.  Joanna graduated from the University of Rochester with a B.S. in Microbiology, a B.A. in German, and a masters in public health. Joanna received her J.D. from Boston College Law School in 2008.  She is a biotech, pharma, medical device and intellectual property consultant, and is also a adjunct lecturer at Harvard School of Public Health where she teaches a course on intellectual property and health technologies.

Congrats, Joanna!

More info on Boston’s Rising Stars

MBBP Client Implant Sciences Corporation Achieves Milestone With QS-B220 09/02/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Computer Software & Hardware, Industries, Intellectual Property, MBBP news.
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9-2-2014 12-36-18 PMMBBP client Implant Sciences Corporation, a company that develops and manufactures explosive trace detection sensors and systems, announced that its QS-B220 desktop explosives trace detector has successfully completed the certification process for the United States Transportation Security Administration’s (TSA) Explosive Trace Detection (ETD) qualification requirements for aviation checkpoint and checked baggage screening.

This announcement marks a major milestone for the company; having the QS-B220 added to the TSA’s Qualified Product List is one of the highest levels of recognition in the security industry and one of the most difficult to achieve,” according to Todd Silvestri, Implant Sciences’ Vice President of Technology.

President and CEO, Glenn D. Bolduc, stated    “We’re very proud to be able to deliver this innovative product for the protection of travelers in our country. Every member of the Implant Sciences team has done a phenomenal job of getting us to this point.”

 

 You can read Implant Sciences’ complete announcement here.

 Well done, Implant Science Corporation!

 

 

MBBP’s Daniele Ouellette Levy to Host Office Hours at TechSandBox 09/17/2014 08/26/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Corporate, Events.
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Corporate Attorney Daniele Ouellette LevyOn September 17, MBBP Attorney Daniele Ouellette Levy will host Office Hours at TechSandBox on Stock and Corporate Structure. Office Hours provides access to experts in topics such as intellectual property, business formation, benefits, taxes, marketing, sales, funding, IT and technology commercialization. Daniele will be available for one-on-one, 45 minute sessions from 9:00AM- 3:00PM. This event will be offered probono for TechSandBox members and to non-members as space allows.

Slots are already filling! Sign up for Office Hours

Want To Stay Employed as a CIO? Better Get Privacy Right 08/25/2014

Posted by Morse, Barnes-Brown Pendleton in Computer Software & Hardware, Intellectual Property, Internet and E-Commerce, Legal Developments, Privacy and Data Security.
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Consumer privacy is emerging into a big headache for companies — and the CIO is bearing the brunt. Most companies analyze customer data in some way, and there are increasing amounts of legislation around how such data handling should be performed. Breaking the rules can land a company in hot water — and leave the CIO out of a job. Sensitive information is often copied from system to system by staff with little understanding of  privacy issues and risks surrounding sensitive data. As a result, it falls to the CIO to make sure that a customer privacy strategy is in place. To properly ensure consumer privacy, the CIO should make sure their company is complying with existing regulations, but also be prepared for possible data breaches.

To read the full article

Understanding the rapidly changing landscape of privacy and data security laws is critical for any business. For more information on how MBBP counsels clients in this area, visit our Privacy & Data Security practice or check out our related resources.

Ten Crucial Questions to Answer Before Contacting a Patent Attorney 08/25/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Intellectual Property, MBBP news.
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Managing Partner and Patent Attorney Lisa TreannieDon’t be fooled by the ads you see promoting the quick filing of a pat­ent application. MBBP’s Lisa Warren gives some insight on why it is important to communicate with a patent attorney when filing a patent application. By considering your invention and preparing the right questions before contacting an attorney, you’ll be sure to save valuable time and money. Are you fully prepared to file for your patent?

To read the full article

For more information on this topic, please contact Lisa Warren.

Second Biosimilar Application Filed Under BPCI Act by Celltrion 08/13/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney David FazzolareBy: David Fazzolare and Joanna Brougher

On August 8, 2011, Celltrion announced that it filed a biosimilar application under the Biologics Price Competition and Innovation Act (BPCI Act) for its infliximab biosimilar.  Celltrion’s infliximab biosimlar is already marked in over 50 countries worldwide, including Europe, Canada and Japan, under the brand name of Remsima®.  Celltrion’s announcement comes shortly after Sandoz’s recent announcement that thePatent Attorney Joanna Brougher FDA had accepted its application for a filgrastim biosimilar application, and marks the second biosimilar application known to be filed under the BPCI Act, as well as the first application for a biosimilar mAb.

For more information on this topic, contact David or Joanna.

David Fazzolare Quoted in FDA Week Biosimilar Article 08/12/2014

Posted by Morse, Barnes-Brown Pendleton in Attorney News, Intellectual Property, Legal Developments, Life Sciences.
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Patent Attorney David FazzolareOn August 8th InsiderHealthPolicy.com’s FDA Week, an exclusive weekly report on Food and Drug Administration Policy, regulation and enforcement, published an article titledBiosimilar ‘Patent Dance,’ Litigation Could Coincide With Possible Approval. The article discusses the FDA’s recent acceptance of the first biosimilar application from Sandoz for a biosimilar filgrastim, a version of Amgen’s Neupogen. This acceptance of Sandoz’s application has also set off a series of deadlines outlined in statute that will determine which patents the two companies will litigate. MBBP Patent Attorney David Fazzolare was quoted in the article discussing the patent exchange process including several other deadlines before possibly resulting in litigation. David stated:

The earliest that I see anything publicly happening, absent any press releases from Sandoz and Amgen, is March of next year.

The same two companies are currently engaged in litigation over patents related to a different product, Enbrel, which is currently on appeal in the U.S. Court of Appeals for the Federal Circuit and oral arguments are slated for Sept. 10.

For more information on this topic, please contact David Fazzolare.

FDA Releases Guidance for Determining Biologic Exclusivity Under the BPCI Act 08/08/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney David FazzolareBy: David Fazzolare & Joanna Brougher

On August 4, 2014, the Food & Drug Administration (FDA) released its latest guidance in a series of guidance documents issued as part of its ongoing effort toward implementing a biosimilar approval pathway under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  In contrast to previously released guidance which dealt with the scientific and regulatory considerations involved inPatent Attorney Joanna Brougher reviewing biosimilar applications, such as the clinical pharmacology data required to demonstrate biosimilarity to a licensed biologic, this latest guidance outlines the FDA’s current thinking with respect to determining whether a licensed biologic is entitled to the exclusivity provided for in Section 351(k)(7)(C) of the Public Health Service Act (PHS Act), as amended by the BPCI Act.

To spur the development of innovative and lifesaving biologic medicines, the BPCI Act amended the PHS Act to award periods of exclusivity to certain licensed biologics during which the FDA is prohibited from taking certain actions with respect to an application for a biosimilar version of those licensed biologics.  The Act provides two relevant exclusivity periods which are both calculated from the date on which a licensed biologic was first licensed.  The guidance refers to this date as the date of “first licensure.”  Section 351(k)(7)(C) provides that licensure of an application for a biosimilar or interchangeable product under the BPCI Act may not be made effective until 12 years after, or submitted to the FDA for review until 4 years after, the date of first licensure of the licensed biologic referenced in the biosimilar application. Thus, establishing the date a licensed biologic was first licensed is critical to determining when the licensed biologic’s exclusivity ends and thus when biosimilar and interchangeable products may enter the market.

Typically, the date of first licensure is the initial date a given biologic product is licensed under 351(a).  Not every licensure of a biological product under 351(a), however, is considered a “first licensure” that gives rise to its own exclusivity period.  To assist stakeholders and reviewers at the FDA in determining whether licensure of a biologic product under 351(a) gives rise to its own exclusivity period, the guidance outlines circumstances in which a licensure would not be considered a “first licensure.”  For example, the date of first licensure does not include the date of licensure for a supplement for the biological product that is the reference product, or a subsequent application by a biologic manufacturer or sponsor (or related entity) for a change to a licensed biologic that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength, or a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.  In other words, for the date of licensure of a modified version of a biologic licensed under 351(a) to be considered the date of first licensure, there must be a modification to the structure of the biologic that results in a change in safety, purity, or potency.

The guidance notes that the FDA intends to determine on a case-by-case basis, based on data submitted by the sponsor, whether a structural modification to a licensed biologic results in a change in safety, purity, or potency that is sufficient to trigger its own exclusivity period.  However, the guidance does not elaborate on how significant those changes must be for the modified biologic to obtain its own exclusivity period.  In this manner, the guidance falls short of providing much needed certainty on the topic.  It is important to remember, however, the guidance has not yet been finalized by the FDA and is subject to change.  Moreover, in releasing the guidance that the FDA passed another major milestone toward implementing the biosimilar approval pathway created by the BPCI Act and shed some light on the topic of biologic exclusivity.

For more information on this topic, contact David or Joanna.

OYO Sportstoys Featured on WBZ-TV 08/04/2014

Posted by Morse, Barnes-Brown Pendleton in Client News, Licensing & Strategic Alliances.
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OYO Sportstoys, Inc.MBBP client OYO Sportstoys, Inc. was recently featured on a segment of WBZ-TV discussing its factory in Acton, Massachusetts that is creating mini sports figures of famous athletes. OYO has licensing agreements with MLB, the NFL and the NHL which allows them to use the names of all players. They hope to get a deal with the NBA soon asPatrice Bergeron OYO Figure well. OYO figures are compatible with other notable building block toys like Lego, Kinex, Mega Blocks and more. Each little OYO mini-figure is customized to look like the real player and gets a little water bottle and a football, baseball or hockey stick.

Congratulations OYO!

Check out the full video here: Acton Company Doing Big Business Making Little Plastic People

MBBP Event: Unfair Competition and False Advertising 07/30/2014

Posted by Morse, Barnes-Brown Pendleton in Events, Intellectual Property.
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Intellectual Property Attorney Sheri MasonOn August 12th MBBP is hosting a seminar on Unfair Competition/False Advertising: How the Supreme Court’s recent decisions impact false advertising claims against competitors. The Supreme Court recently issued two decisions, Lexmark International, Inc. v. Static Control Components, Inc. and POM Wonderful LLC v. Coca-Cola Co., which impact rights a party may have against competitors for false advertising claims under the Lanham Act. This seminar, presented by MBBP Trademark Attorney Sheri Mason, will discuss unfair competition and false advertising under the Lanham Act, the Lexmark International, Inc. v. Static Control Components, Inc.and POM Wonderful LLC v. Coca-Cola Co. decisions, and how these decisions may affect your rights against third parties.

To learn more or to register, please visit our events page.

For more information on false advertising, please feel free to contact Sheri directly.

Consultant or Executive Officer? SEC Brings an Action to Clarify 07/30/2014

Posted by Morse, Barnes-Brown Pendleton in Public Companies.
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By: Mark Tarallo

On July 16, 2014, the United States Securities and Exchange Commission (“SEC”) brought an action against Natural Blue Resources, Inc. (“Natural Blue”), James E. Cohen (“Cohen”) and Joseph A. Corazzi (“Corazzi”)(Natural Blue, Cohen and Corazzi are referred to collectively as the “Respondents”).  The SEC is seeking a cease-and-desist order against the Respondents, alleging among other items that Cohen and Corazzi acted as the de facto executive management of Natural Blue, while failing to make any of the disclosures required of executive officers of a public company.

Natural Blue was a privately-held corporation based in Nevada that went public in August, 2009 via a reverse merger with Datameg Corporation.  In November 2009, Natural Blue entered into a consulting agreement with JEC Corp. (“JEC”) a corporation owned by Cohen’s family.  Cohen was the President of JEC, and  Corazzi was employed by JEC.  Cohen and Corazzi each had extensive disciplinary histories that would have prevented them from serving as an executive officer of Natural Blue.

From the time that Natural Blue went public in 2009 through the end of 2011, Cohen and Corazzi exercised a significant degree of control over Natural Blue through JEC.  They recommended virtually all of the directors that served on the board of Natural Blue, and almost all of the key executive positions were filled by individuals with whom they had significant preexisting business or social relationships.  Despite the fact that Natural Blue had a named CEO, Cohen and Corazzi controlled all of the key functions of Natural Blue, such as the accounting department (the CFO was an associate of Cohen’s with whom Cohen shared outside office space).  Cohen and Corazzi dealt directly with third parties and purported to enter into agreements on behalf of Natural Blue.  Despite the fact that the actions of Cohen and Corazzi did not actually generate any revenue for Natural Blue or its shareholders, they were paid significant amounts of cash and Natural Blue stock (which was sold at a profit) for their efforts.

The SEC’s action alleges among other things that the Respondents engaged in fraud by failing to accurately report the roles played by Cohen and Corazzi, and that those failures caused harm to investors.  Given the disciplinary histories of Cohen and Corazzi, it is clear why they went to the lengths that they did to hide their actual roles.  The SEC filing can be found here.

For more information on this topic, please feel free to contact Mark Tarallo.

 

Biosimilars Developers Watch Closely as FDA Accepts First Biosimilar Application from Sandoz 07/29/2014

Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
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Patent Attorney David FazzolareBy: David Fazzolare & Joanna Brougher

Sandoz, a Novartis Group company, announced on July 24, 2014 that the US Food and Drug Administration (FDA) has accepted for review its application for a biosimilar version of filgrastim. The reference product, Neupogen®, which brought maker Amgen Inc. $1.4 billion in sales in 2013, is a biologic used to prevent
infections in cancer patients getting certain treatments that result in a decrease in infection-fighting whitePatent Attorney Joanna Brougher blood cells.  Sandoz’s application for filgrastim is the first biosimilar application known to have been accepted by the FDA for review since the Biologics Price Competition and Innovation Act (BPCIA) established an approval pathway for biosimilars in 2009.  Sandoz’s biosimilar filgrastim has already been approved in more than 40 countries outside the US under the brand name Zarzio®, including in Japan and Europe, and could be the first biosimilar approved in the US under the BPCIA.  Such biosimilars could offer patients more affordable alternatives to existing biologic medicines similar to the way that generic drugs approved under the Hatch Waxman Act offer patients more affordable alternatives to their brand-name counterparts.

Sandoz’s announcement came shortly after the FDA released its draft guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”  The FDA had previously released three draft guidance documents outlining the FDA’s then-current thinking on important scientific and regulatory considerations relevant to submitting biosimilar applications, however, none of the industry guidance documents have yet been finalized.  More importantly, none of the guidance documents provide clarity on the evidentiary thresholds required by the FDA to obtain interchangeability status for a biosimilar, which is required before an approved biosimilar can be substituted for a prescribed biologic without first consulting the prescribing physician.  Although it is unclear whether Sandoz is pursuing interchangeability status for its biosimilar version of fligrastim, the FDA’s review of Sandoz’s application could provide much needed clarity on this as well as other issues related to the approval pathway for biosimilars.  As the FDA weighs approval of Sandoz’s application, drugmakers are certain to gain insights on how the FDA will review future biosimilar applications.

For more information on this topic, contact David or Joanna.

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