Tags: biotech, innovation, Life Sciences, Massachusetts Life Sciences Center
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MBBP client, Selvita, recently announced an expansion into the Boston-area biotechnology and pharmaceutical market, as they open a fully-owned US subsidiary, Selvita Inc., headquartered in Cambridge, Massachusetts. Selvita is a leading global drug discovery company and the largest drug discovery company in Central and Eastern Europe. The new office, located at 485 Massachusetts Ave., will focus largely on expanding the company’s existing clients for its drug discovery services, as well as exploring and developing partnering opportunities.
“We are excited to celebrate the official opening of Selvita’s new office in Cambridge,” said Mike Kennealy, Acting President & CEO of the Massachusetts Life Sciences Center, a state-funded investment agency that worked closely with Selvita on their location decision. “The company’s presence here will enable Selvita to make important contributions to the Massachusetts life sciences community and to drug development, in the world’s leading ecosystem for life sciences innovation and growth.”
Read the full news release here.
Tags: Boston Tech, entrepreneurs, Team Tequila, Team Wine, TUGG, venture capital, Wine and Tequila Party
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On Thursday, April 16th, MBBP will be sponsoring the TUGG 9th Annual Wine and Tequila Party. Join 1,500+ of Boston tech’s entrepreneurs, venture capitalists, and philanthropists as we raise $400K+ to support six local nonprofits, while enjoying top-shelf wine and tequila. The non profits at this year’s party will consist of three returning favorites from the TUGG portfolio, and three new and promising ones. Meet and mingle with representatives from these nonprofits and hear their stories during the event. Then cast your votes for your favorite returning and your favorite new nonprofit. The winning non profit will be awarded up to $50,000.
Don’s miss out! Learn more and register for the TUGG 9th Annual Wine and Tequila Party.
Tags: biotechnology, Life Sciences, massbio, Trends in Science
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The MassBio Annual Meeting is a two day event that focuses on the most timely and critical challenges facing the Massachusetts biotechnology industry. As MassBio’s largest event, drawing close to 400 industry leaders, the meeting program is compiled by a Steering Committee and includes keynote presentations, plenary discussions, two panel tracks (Better Business and Trends in Science), and extensive networking opportunities.
For more information contact MassBio.
Tags: Amgen Inc., Apotex Inc., biosimilars, FDA, neupogen, Sandoz
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On February 18, 2015, Apotex Inc., announced that the Food and Drug Administration (FDA) had accepted its application for a biosimilar version of Amgen Inc’s Neupogen®. Apotex is second to Sandoz Inc. to propose a biosimilar version of Neupogen® (filgrastim), which is administered during chemotherapy to boost white blood cell counts and help fight infections. This is Apotex’s second biosimilar application, following Neulasta® (pelfilgrastim), a long-acting version of Neupogen®, filed last year. The approval of both Sandoz’s and Apotex’s Neuopogen(r) biosimilar applications could shed some light on the extent to which biosimilars will impact biologic sales.
Apotex hopes its biosimilar will be designated as an “interchangeable” product under the Biosimilars Act, which means that pharmacists filling prescriptions for Neupogen(r) could potentially substitute it without consulting the prescribing physician. However, it it is unclear whether it will benefit from the exclusivity period awarded to the first interchangeable product in view of Sandoz’s earlier filed Neupogen(r) biosimilar application. Even though Sandoz has publicly stated that it is not seeking interchangeability status for its Neupogen® biosimilar product, if the FDA nevertheless designates it as interchangeable Apotex would not be entitled to exclusivity for its Neupogen® biosimilar, and would have to wait until Sandoz’s exclusivity expired before the FDA would designate Apotex’s Neupogen® biosimilar as interchangeable. On the other hand, if the FDA does not designate Sandoz’s Neupogen® biosimilar as interchangeable, then Apotex’s biosimilar could be designated as interchangeable, as well as benefit from the exclusivity awarded to the first biosimilar to receive designation as interchangeable.
For more information on this topic, please contact David A. Fazzolare or Joanna T. Brougher.
Tags: alliances, licensing, Life Sciences, rights of first refusal, strategic partnerships, technology companies
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When entering into an exclusive licensing arrangement, the odds of success are against most companies. Typically within the first twelve months of an arrangement, 2/3 of all alliances crumble. If these ventures are so prone to failure, what preventative measures can a company employ to ensure success?
To learn how to achieve success when entering an alliance, read John Hession’s full article.
Tags: Amgen, biosimilars, FDA, Sandoz
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By: David Fazzolare
On January 5, 2015, the US Food and Drug Administration’s (“FDA’s”) Oncologic Drugs Advisory Committee (the “Committee”) announced its recommendation that the FDA approve Sandoz Inc.’s application to market Zarxio® (EP2006), a biosimilar version of Amgen, Inc.’s Neupogen® drug. The Committee explained its recommendation in a 62-page, publicly-issued briefing document. Zarxio® is the first drug reviewed by the Committee under new biosimilars provisions enacted as part of the Patient Protection and Affordable Care Act. The Committee’s recommendation is therefore a key step forward not only for Zarxio®, but also for implementation of the new biosimilars provisions (known as the Biologics Price Competition and Innovation Act of 2009, or “BPCIA”).
Sandoz is not yet seeking interchangeability status for Zarxio®, a designation which allows pharmacists to substitute biosimilars in place of prescribed reference biologics—i.e., Zarxio® in place of Neupogen®. Sandoz told the Committee it plans to file for interchangeability only after Zarxio® is fully approved as a biosimilar.
The Committee’s recommendation, while a milestone for the drug and the FDA, does not automatically clear the way for approval of Zarxio®. The Committee noted that the lack of comparative data available left some “residual uncertainty about whether ADA [anti-drug antibodies] incidence is similar in subjects administered [Zarxio®] and … Neupogen®.” On January 7, 2015, the FDA will take testimony from experts, who may weigh in on this issue, and provide their own recommendations as to whether the FDA should approve Zarxio® as a Neupogen® biosimilar. The FDA will then undertake a full review of Zarxio®. In the background is Amgen’s pending federal lawsuit against Sandoz, brought on October 24, 2014, which alleges Sandoz’s conduct violated the procedures required by the BPCIA. Amgen also submitted a citizen’s petition to the FDA on October 29, 2014, asking that the FDA require biosimilar applicants to fully comply with all BPCIA procedures. How the Committee’s recommendation will affect these filings remains unclear.
For more information, please contact David Fazzolare.
Federal Circuit in Sandoz v. Amgen Upholds District Court Ruling on Standing Requirements in Biosimilars Cases 12/19/2014Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences, Medical Devices, New Resources.
Tags: Amgen, biosimilars, clinical trials, Enbrel, FDA, Sandoz
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The recent back and forth between Amgen and Sandoz took another dramatic turn on December 5, 2014, when the Federal Circuit affirmed the district court’s dismissal of Sandoz’s declaratory judgment lawsuit against Amgen because Sandoz’s alleged injury did “not meet the requirements of immediacy and reality” necessary for standing. Regarding immediacy, Judge Taranto noted that Sandoz had brought the suit at a time when it was years away from completing its Phase III clinical trials for its Enbrel® biosimilar. Obtaining FDA approval would further push back the earliest possible date on which Sandoz could hope to market its drug. Regarding reality, Judge Taranto further opined that it was possible that Sandoz’s biosimilar would never infringe the patents licensed to Amgen. For example, Sandoz’s drug could fail completely in Phase III trials and never be approved by the FDA; the drug might also require modifications making it dissimilar enough from Enbrel® as to prevent infringement, even while remaining biosimilar. For those reasons, Judge Taranto concluded Sandoz could not demonstrate that either of these possibilities was “so unlikely to arise” that Sandoz could show it had a concrete injury in the pipeline.
While seemingly fact-specific, the Federal Circuit’s decision may have larger ramifications for future cases involving the BPCIA. Judge Taranto noted in his opinion: “The biosimilarity approval standard is new; indeed, the FDA has not yet applied the new standard to complete its review of and approve any product under the BPCIA.” Yet elsewhere in the opinion, Judge Taranto suggested that the Federal Circuit, at least, had an idea of how courts should evaluate BPCIA cases. He wrote: “Our conclusion is consistent with our cases under the Hatch–Waxman Act. As noted above, we have found no justiciability where a declaratory-judgment plaintiff had not filed an application for the FDA approval required to engage in the arguably infringing activity. On the other hand, where we have found a case or controversy in the Hatch–Waxman setting, we have focused on the presence of an application for the required FDA approval.” Thus Sandoz’s failure to submit a biosimilar application to the FDA before filing seeking its declaratory judgment seems to have played a role in the outcome of the case.
The Federal Circuit’s decision to consider this BPCIA ruling’s conformity with Hatch–Waxman may be due to the fact that the BPCIA provision under which Sandoz’s brought suit was directly “borrow[ed] from” Hatch–Waxman. Whether other courts hearing BPCIA cases will look to Hatch–Waxman or view this part of the Federal Circuit opinion as dicta remains to be seen.
The Federal Circuit ultimately declined to review the district court’s alternative grounds for dismissal involving Sandoz’s failure to comply with BPCIA procedures, limiting the extent of its holding. While Sandoz may appeal this decision to the Supreme Court, it is clear for now that parties must continue to carefully evaluate standing prior to bringing a patent infringement suit under the BPCIA.
For more information on this topic, please contact David A. Fazzolare.
Tags: biologics, biosimilars, drugs, FDA, generic drugs, hatch-waxman, patent, reference
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On 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 lists 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.
Tags: Best Lawyers, biotech, Boston's Rising Stars, health technologies, Intellectual Property, medical devices, National Law Journal
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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.
More info on Boston’s Rising Stars
MBBP Attorney Helps Fight Cancer: PMC 2014 08/19/2014Posted by Morse, Barnes-Brown Pendleton in Attorney News, Life Sciences, MBBP news, Nonprofit.
Tags: Cancer Research, Dana-Farber, Pan Mass Challenge, PMC, The Jimmy Fund
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This year, MBBP Partner Mike Cavaretta completed his tenth Pan Mass Challenge. The PMC is a two-day 194-mile bike ride across Massachusetts from Sturbridge to Provincetown to raise money for The Dana-Farber Cancer Institute.
“Why do I do it? Some people might say it’s because I’m crazy. Others might say it’s for the free beer (Harpoon!). And still others might say it’s for the challenge and the camaraderie. They’d all be right. But the main reason I do it is to help wipe out cancer”
The Pan Mass Challenge has raised more money for charity than any other event in the country. Their goal this year is to raise $40 million dollars by October 2014, 100% of which will go to Dana-Farber and the Jimmy Fund. To donate on Mike’s (or other riders’) behalf please visit the PMC website.
Congrats, Mike! Well done!
Tags: biologics, biosimilar, BPCI Act, celltrion, FDA, infliximab, remsima, Sandoz
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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 the 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.
Tags: Amgen, biosimilars, FDA, FDA Week, insiderhealthpolicy.com, patent, Sandoz
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On August 8th InsiderHealthPolicy.com’s FDA Week, an exclusive weekly report on Food and Drug Administration Policy, regulation and enforcement, published an article titled “Biosimilar ‘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.
Tags: application, biologic, Biologics Price Competition and Innovation Act, biosimilars, BPCI Act, drugmakers, FDA, PHS Act
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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 in 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.
Biosimilars Developers Watch Closely as FDA Accepts First Biosimilar Application from Sandoz 07/29/2014Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
Tags: application, biologic, biosimilars, drugmakers, FDA, filgrastim, neupogen, Sandoz
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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 white 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.
Tags: biological products, biosimilar, FDA, pharmacist, vaccines, viruses
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By: Stanley Chalvire
Massachusetts recently enacted Chapter 143 of the Acts of 2014, entitled “An Act relative to the substitution of interchangeable biosimilars,” authorizing pharmacists to fill prescriptions that are written for brand name biological products with the corresponding and generally less expensive biosimilar product. A biosimilar is a biological medicine that the U.S. Food and Drug Administration (FDA) has determined is highly similar to an FDA-approved biological product, notwithstanding minor differences in inactive components, for which there are no clinically meaningful differences between such biosimilar product and the reference biological product in terms of safety, purity and potency.
The Act defines “biological product” to include, for example, viruses, vaccines, blood components or derivatives and certain proteins that are applicable to the prevention, treatment or cure of a disease or condition of human beings. An “interchangeable prescription biological product” is defined as a biosimilar that has been determined by the FDA to be substitutable with the prescribed reference biological product.
The Act generally tracks existing Massachusetts laws governing the substitution of generic drugs for prescribed brand name drugs. In particular, the Act provides that:
- A pharmacist filling a prescription for a biological product prescribed by its trade or brand name may substitute an interchangeable biological product;
- The prescriber can instruct against substitution of an interchangeable biological product on a patient-specific basis;
- The dispensing pharmacist or the pharmacist’s designee must notify the prescribing practitioner and the patient of the substitution;
- The dispensing pharmacist or the pharmacist’s designee, the prescribing provider and administering practitioner shall retain a record of each substitution, for not less than 1 year from the date of the last entry in the profile record; and
- In the event of noncompliance by a pharmacist or a practitioner, the purchaser or patient may inform the director of consumer affairs and business regulation of such noncompliance.
The FDA has yet to approve a biosimilar product, much less an interchangeable biosimilar product which pharmacists in Massachusetts would be permitted to substitute under the Act. Massachusetts now joins Florida, North Dakota, Oregon, Utah, Virginia and Indiana on the forefront of states enacting laws governing the substitution of biosimilars.
For more information on the Act or biosimilars, please contact Stan Chalvire.
Tags: biotech, IPO, public offering, stock
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On March 7, the Boston Business Journal (BBJ) published an article titled “A year of biotech IPOs: Where is their stock price now?” which highlights fourteen local biotech companies that went public last year, ranking them by their stock increase seen since the close of their first day on the market until the March 6 close. A year ago this month, Enanta Pharmaceuticals and Tetraphase Pharmaceuticals, both of Watertown, MA, became the first two Massachusetts biotech firms to go public in what turned out to be the busiest biotech IPO boom in more than a decade.
To see the full list visit the BBJ.
Tags: AIA, biologics, biosimilar, patent litigation, sandoz v. amgen
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By: David Fazzolare
In December 2013, the court case of Sandoz v. Amgen became the first instance in which a court has been asked to interpret the patent litigation provisions of the Biologics Price Competition and Innovation Act (the “Biosimilars Act”), the outcome of which may have significant impact on future biosimilar development.
To learn what this means for biosimilar applicants, see the full article.
Please feel free to contact David with any questions on this topic.
Tags: drug products, FD&C Act, FDA, NCE, new drug application
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By: Stanley Chalvire
In an effort to incentivize the development of certain fixed-combination drug products, the Food and Drug Administration (FDA) recently issued draft guidance revising its interpretation of the 5-year New Chemical Entity exclusivity provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act).
Sections 505(c)(3)(E) and 505(j)(5)(F) of the FD&C Act provide the holder of an approved New Drug Application with the benefit of limited protection from certain competition (e.g., generic competition) in the marketplace. In particular, newly approved drug products that contain an active ingredient that has not been previously approved by FDA (a so-called “new chemical entity”) are eligible for 5-years of New Chemical Entity (NCE) exclusivity and, with one exception, during such 5-year exclusivity period, third party applications referencing the newly-approved drug cannot be submitted to FDA.
Fixed-combination drug products are combinations of two or more active ingredients in a single dosage form or drug product. FDA has historically interpreted the 5-year NCE exclusivity provisions of the FD&C Act such that fixed-combination drug products that contained a previously-approved drug product were not eligible for 5-year NCE exclusivity, irrespective of whether such fixed-combination drug product contained a new chemical entity.
Based on FDA’s recognition of the increasing prevalence of fixed-combination drug products in certain therapeutic areas (e.g., cancer and infectious diseases, such as HIV) and the role that such combination products play in optimizing adherence to dosing regimens and improving patient outcomes, FDA has revised its interpretation of the 5-year NCE exclusivity provisions. As a result of FDA’s revised interpretation, a 5-year NCE exclusivity determination will be made on the basis of each active ingredient in a drug product, such that a drug product that includes a new chemical entity will be eligible for 5-year NCE exclusivity, regardless of whether that drug substance is approved alone or in a fixed-combination. FDA is soliciting comments in response to its draft guidance until April 25, 2014.
For more information or to discuss FDA’s new interpretation of the NCE provisions, please contact Stan Chalvire.