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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Sandoz’s announcement came shortly after the FDA released its draft guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”  The FDA had previously released three draft guidance documents outlining the FDA’s then-current thinking on important scientific and regulatory considerations relevant to submitting biosimilar applications,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.

Massachusetts Enacts Biosimilar Substitution Law 07/22/2014

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Patent Attorney Stan ChalvireBy: 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.

FDA Revises Interpretation of 5-year NCE Exclusivity 03/11/2014

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Patent Attorney Stan ChalvireBy: 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.

FDA to Partner with Industry to Help Expedite Medical Device Development 12/04/2012

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, New Resources.
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Patent Attorney David FazzolareBy David A. Fazzolare

The FDA issued a press release December 3, 2012 announcing its role in a new public-private partnership aimed at expediting medical device review and approval by improving the regulatory science underlying medical device development, assessment and review. In particular, the biomedical science trade association LifeScience Alley (LSA) created the Medical Device Innovation Consortium (MDIC) as an independent, nonprofit corporation that will garner input from stakeholders, including industry, government, and other nonprofit organizations to better understand the regulatory science needs of the medical device industry and provide funding for projects that will simplify medical device design and market approval. The FDA plans to collaborate with MDIC on its supported research and projects.

For additional information, please contact David A. Fazzolare.

FDA Clears MindChild Medical’s Fetal Monitor 10/23/2012

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In February we reported that MBBP client MindChild Medical Inc. had filed for a Pre-Marketing Notification Application (510(k)) with the U.S. Food and Drug Administration for its non-invasive fetal heart rate monitor, MERIDIAN™.  On September 25, MindChild announced that the FDA has cleared MERIDIAN™ and anticipates it entering the U.S. markets in the near future. Bill Edelman, CEO of MindChild, had this to say of the achievement:

We are thrilled to have reached this milestone. MERIDIAN is the first in a series of non-invasive fetal monitor technologies developed by MindChild that are intended to provide the healthcare community enhanced monitoring capabilities for both fetal heart rate and fetal ECG. We anticipate significant clinical interest for this innovative technology in the markets where MERIDIAN will be cleared for commercial distribution.

Congratulations MindChild!

Please view the press release for more information.

FDA Releases Long-Awaited Draft Guidance on Biosimilars 02/13/2012

Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences.
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Patent Attorney David FazzolareBy: David Fazzolare

The long-awaited guidance on biosimilar product development has finally been released by FDA. On Thursday, February 9th, FDA released three guidance documents on biosimilar product development which reflect the agency’s current thinking on important scientific and regulatory considerations pertinent to submitting biosimilar applications.

The first guidance document, entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, focuses on therapeutic protein products, and aims to help biosimilar applicants show that a biologic is biosimilar to a licensed biologic.

The second guidance document, entitled “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product”, details analytical considerations (e.g., biological characterization) involved in evaluating biosimilarity.

The third guidance document, entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009”, addresses common questions biosimilar applicants may face in developing biosimilars, particularly in early product development stages.

FDA is expected to publish a request for public comments on the draft guidance documents in the Federal Register, and will consider such comments while finalizing its guidance.

Contact David A. Fazzolare for more information.

MindChild Medical Looks for FDA Approval 02/06/2012

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MBBP client MindChild Medical Inc. recently announced it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the U.S. Food and Drug Administration for Meridian, a non-invasive fetal heart rate monitor. MindChild Medical expects the FDA to provide feedback on the 510(k) application in the next quarter, and also plans to begin marketing Meridian, based on expected approval, once it receives FDA clearance.

For more information, please see the full press release.

FDA to Meet on December 16 to Discuss Proposed User Fee Program for Biosimilar and Interchangeable Biologic Product Applications 12/09/2011

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Patent Attorney David FazzolareBy David Fazzolare

The FDA recently announced a notice of public meeting and request for comments in the Federal Register regarding proposed recommendations for a user fee program for biosimilar biological products for fiscal years 2013 through 2017. The Federal Register notice describes the FDA’s proposed user fee program, as well as FDA’s proposed performance goals and procedures.

The public meeting will be held on Friday, December 16, 2011, from 9 a.m. to 1 p.m at FDA’s White Oak Campus in Silver Spring, MD. Registration to attend the meeting must be received by December 14, 2011. The FDA requests that electronic or written comments be submitted by January 6, 2012. Further details on how to register or submit comments can be found here.

The proposed recommendations include four types of fees, including biosimilar product development (BPD) fees, marketing application fees, and establishment and product fees, which are summarized briefly below.

The FDA proposed biosimilar product development fees include an initial BPD (Biosimilar Product Development) fee for each product and an annual BPD fee. Sponsors are required to pay only a single initial BPD fee for each product no matter how many indications are proposed for the product. The initial BPD fee for each fiscal year from 2013 to 2017 is proposed to be 10 percent of the human drug application fee established under PDUFA for that fiscal year. Each year thereafter an annual BPD fee is due on or before October 1 until a marketing application that is submitted by the sponsor is accepted for filing or the sponsor stops participating in the BPD program.

The FDA proposed that the marketing application fee be equivalent to the human drug application fee established under the Prescription Drug User Fee Act (PDUFA), less any cumulative BPD fees already paid for the biologic product. The FDA also proposed that the product establishment and product fees be equivalent to the establishment and product fees established under PDUFA for any given fiscal year.

For more information, check out the FDA’s notice published in the Federal Register or contact David Fazzolare.

FDA Approves Pluromed Surgical Gel 10/20/2011

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MBBP client Pluromed, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved their surgical gel, LeGoo® Internal Vessel Occluder. LeGoo is a water-soluble temperature-sensitive medical device that allows doctors to temporarily stop blog flow during surgery without using clamps or elastic loops. Pluromed plans to start commercializing LeGoo at select medical centers in the US in early 2012. President and CEO of Pluromed, Jean-Marie Vogel, had this to say of the announcement:

The FDA has, among other responsibilities, the mission to protect the public health by assuring the safety, effectiveness, and security of medical devices. The approval of LeGoo shows that it can fulfill that mission and yet approve innovative devices with the potential to change the way surgery will be done in the future.

Congratulations Pluromed!

For the full press release, please click here.

MBBP Client Valeritas Receives FDA 510(k) Clearance for Insulin Delivery Device 03/17/2011

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MBBP client Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, has gained clearance from the U.S. Food and Drug Administration on the company’s V-Go Disposable Insulin Delivery Device for use with Novo Nordisk’s NovoLog® for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. At the end of 2010, Valeritas received FDA clearance for the V-Go’s use with Eli Lilly’s Humalog®.

Valeritas’ V-Go is the first simple, fully disposable device for the delivery of basal-bolus insulin therapy for adults with diabetes, and it is the first use of the Valeritas h-Patch technology.

For more information, visit www.valeritas.com.

European Commission Approves Shire’s Gaucher Drug 09/15/2010

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MBBP client Shire Human Genetic Therapies was recently featured in a Boston Business Journal article. Shire’s Gaucher disease treatment VPRIV  was approved by the European Commission, thereby allowing VPRIV to be marketed in thirty European countries. VPRIV approval by the U.S. Food and Drug Administration in March 2010 was fast-tracked due to the shortage of Genzyme Corporation’s Gaucher drug Cerezyme.

For more information, please visit Shire.

Patient Data Shows Safe Switch from Genzyme to Shire Drug 04/08/2010

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Shire Human Genetic TherapiesDue to the temporary closing of Genzyme’s Allston plant last summer, MBBP client Shire’s new Gaucher Disease treatment VPRIV was fast-tracked and approved by the FDA.

Shire is now reporting data from a Phase 3 study which showed that when patients switched from Genzyme’s Cerezyme to Shire’s VPRIV, in the same dosage, several key health indicators remained the same.

For more information, please visit Shire.

FDA Approves Etex Bone Substitute, CarriGen 03/15/2010

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Etex CorporationMBBP client Etex Corporation, a Cambridge based biomaterials company, reports the FDA has approved its bone substitute product, CarriGen, which it will begin selling immediately. The product, which is a viscous putty made of nanocrystalline calcium phosphate, is a porous bone graft substitute that sets hard on implantation, filling the defect area and is intended to be used to fill holes in the bones of the pelvis, extremities and spine. The artificial bone material creates a scaffold-like structure comparatively as strong as natural bone.

For more information on CarriGen, please visit Etex Corporation.

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