FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Category: Biologics

Posted on Wednesday, June 14 2017 at 3:26 pm by
U.S. Supreme Court Finds that Dancing with Biosimilars is NOT Mandatory

By: Alyson L. Wooten, Pharm.D.

imagesThe U.S. Supreme Court had a busy day on Monday (June 12, 2017) issuing four unanimous decisions in recently argued cases.  Of particular note is the final decision in the Supreme Court’s 2016 term – the consolidated case of Sandoz Inc. v. Amgen Inc. and Amgen Inc. v. Sandoz Inc., which interpreted the Biologics Price Competition and Innovation Act (BPCIA).  As we reported here, this case originated out of the U.S. District Court for the Northern District of California where Amgen sued Sandoz for failure to engage in the BPCIA’s patent dance[1] and for inadequate notice of commercial marketing of Sandoz’s biosimilar version (Zarxio®) of Amgen’s Neupogen® product.

The Supreme Court decided that Sandoz had not violated the BPCIA by failing to engage in the patent dance. The justices found it compelling that the BPCIA expressly sets forth the consequences for failure to provide a copy of the FDA application and manufacturing information as required under 42 U.S.C. § 232(l)(2)(A).  This initial exchange of information sets into motion the patent dance.  The consequences, found in 42 U.S.C. § 232(l)(9)(C), permit the sponsor to bring an immediate declaratory judgment action for patent infringement.  Thus, the Supreme Court found the BPCIA does not require a biosimilar applicant to share its abbreviated biologics application and associated data, and, in the absence of voluntary sharing, a branded biologics developer must use injunctive relief to enforce its patents.  As such, the Supreme Court determined there is no requirement that a biosimilar applicant participate in the patent dance.  However, the Court remanded to the Federal Circuit to determine whether California state law may provide for injunctive relief to enforce 42 U.S.C. § 232(l)(2)(A) based on failure to comply with California’s unfair competition statute.

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Posted on Tuesday, September 6 2016 at 3:39 pm by
Sandoz Wins FDA Approval for First Biosimilar of Amgen’s Enbrel®

By: Jennifer Giordano-Coltart Ph.D.

On August 30, 2016, the Food and Drug Administration (FDA) approved the third U.S. biosimilar product – Sandoz Inc.’s (Sandoz) biosimilar of Amgen Inc.’s (Amgen) blockbuster Enbrel® (etanercept) – pursuant to the Biologics Price Competition and Innovation Act of 2009 (BPCIA).[1] Sandoz’s biosimilar, GP2015, will be marketed as Erelzi® (etanercept-szzs) and has been approved for all indications on the label of its reference product Enbrel®, including ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and rheumatoid arthritis. The approval was expected following the unanimous vote for approval of the FDA’s Arthritis Advisory Committee in July.[2]  In approving GP2015, the FDA concluded that the biosimilar was highly similar to U.S.-licensed Enbrel®, notwithstanding minor differences in clinically inactive components.  FDA also found no clinically meaningful differences between GP2015 and the reference product in terms of the safety, purity, and potency of the product.  Sandoz’s abbreviated Biologic License Application (aBLA) was supported by comparative pharmacokinetic studies in healthy volunteers and a confirmatory efficacy and safety similarity study in patients with chronic plaque psoriasis.  Of note, the results of these studies were extrapolated to support approval of GP2015 for all other indications for which the reference product is approved.  While approved as a biosimilar of Enbrel®, GP2015 was not approved as an interchangeable product, though additional studies may support such a finding in the future.

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Posted on Wednesday, July 6 2016 at 6:19 pm by
Not Optional: Court Rules that Biosimilar Applicants Must Always Give Commercial Marketing Notice

By: Jennifer Giordano-Coltart, Ph.D.

Yesterday, the Court of Appeals for the Federal Circuit added yet another wrinkle to the process of bringing a lower-cost biosimilar to market. In the case of Amgen Inc. v. Apotex Inc.,[1] which involves Apotex Inc.’s (Apotex) biosimilar of Amgen Inc.’s (Amgen) Neulasta® (pegfilgrastim), the Federal Circuit unanimously ruled that a biosimilar applicant must always provide 180-day pre-commercial marketing notice to the biosimilar’s reference product sponsor under the Biologics Price Competition and Innovation Act (BPCIA) regardless of whether the applicant participated in the BPCIA’s patent information exchange procedures (42 U.S.C. § 262(1)) (i.e. the patent dance).    Read the rest of this entry »

Posted on Tuesday, April 12 2016 at 4:40 pm by
What’s In a Name? FDA Releases Draft Guidance on Biosimilar Labeling

By: Carolina M. Wirth and Jennifer Giordano-Coltart, Ph.D.

The Food and Drug Administration (FDA)’s long-awaited draft guidance (Draft Guidance) on biosimilar product labeling was finally issued on March 31, 2016.  The Draft Guidance addresses product labeling requirements for biosimilar products approved under Section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. § 262(k)), referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  Read the rest of this entry »

Posted on Friday, March 25 2016 at 5:00 pm by
Amgen Opposes Supreme Court Review on Pre-Commercial Notice Provision in Amgen v. Sandoz But Files Cross-Petition on Whether Patent Dance Is Mandatory

 By: Jennifer Giordano-Coltart, Ph.D.

We recently posted on Sandoz Inc.’s petition for writ of certiorari that was filed February 16, 2016 requesting U.S. Supreme Court (Supreme Court) review of the U.S. Court of Appeals for the Federal Circuit’s (Federal Circuit) interpretation of the pre-commercialization notice provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In that case, the Federal Circuit held that, “under paragraph (l)(8)(A), a subsection (k) [of the BPCIA] applicant may only give effective notice of commercial marketing after the FDA has licensed its product.”[1] Read the rest of this entry »

Posted on Thursday, February 25 2016 at 5:34 pm by
On the Last Day Sandoz Files Writ of Certiorari Requesting Supreme Court Review

By: Carolina M. Wirth and Jennifer Giordano-Coltart, Ph.D. 

Sandoz Inc. (Sandoz) filed a Petition for Writ of Certiorari (Cert. Petition) on February 16, 2016, requesting U.S. Supreme Court (Supreme Court) review of the U.S. Court of Appeals for the Federal Circuit’s interpretation of the pre-commercialization notice provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The case relates to Sandoz’s abbreviated biologic license application for Zarxio® (filgrastim-sndz), a biosimilar version of Amgen Inc.’s Neupogen® (filgrastim).  Sandoz provided notice of intent to commercialize its biosimilar to Amgen twice: first upon acceptance of its application by the Food and Drug Administration (FDA) and second, eight months later upon approval of the application.  The notice was given pursuant to § 351(l)(8)(A) of the Public Health Services Act (PHS Act), which states that a biosimilar applicant under subsection (k) of the PHS Act “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”

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Posted on Monday, February 15 2016 at 10:29 am by
Sandoz Ramps Up Biosimilar Program: European Biosimilar Application of Amgen’s Neulasta® Accepted; Acquisition of Pfizer Infliximab Biosimilar

By:  Jennifer Giordano-Coltart, Ph.D.

Neulasta® European Biosimilar Application

Sandoz announced on February 11, 2016 that its Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta® (pegfilgrastim) was accepted for review by the European Medicines Agency (EMA).1 This follows the Federal Drug Administration (FDA) acceptance of Sandoz’s 351 (k) abbreviated Biologic License Application (aBLA) for pegfilgrastim fled in November, 2015, which used Amgen’s U.S.-approved Neulasta® as the reference product.2 Read the rest of this entry »

Posted on Friday, January 22 2016 at 4:25 pm by
BIO and PhRMA Citizen Petition Calls For Detailed Information on Biosimilar Labeling

By:  Jennifer Giordano-Coltart, Ph.D.

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) filed a Citizen Petition (“Petition”) with the Food and Drug Administration (FDA) on December 22, 2015.[1]  The Petition focuses on the labeling requirements for biosimilar biological products licensed under section 351(k) of the Public Health Service Act (PHS Act), as amended by the Biologics Price Competition and Innovation Act (BPCIA). Read the rest of this entry »

Posted on Thursday, January 14 2016 at 4:19 pm by
AbbVie to FDA: Clinical Support Needed For All Reference Product Approved Indications to Support Interchangeability Designation for Biosimilars

By: Jennifer Giordano-Coltart, Ph.D. and Carolina M. Wirth

On December 16, 2015, AbbVie, Inc. (AbbVie) submitted another Citizen Petition (Petition) to the Food and Drug Administration (FDA) relating to the Biologics Price Competition and Innovation Act (BPCIA) (Docket No. FDA-2015-P-4935).1 The Petition focuses on the standard to be used to determine whether a biosimilar product may be designated as interchangeable with a reference product under Public Health Service Act (PHS Act) §351(k)(4).2 An interchangeable biological product is a product that has established biosimilarity to an FDA-approved reference product and meets additional standards. Such a product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.3 AbbVie takes the position that interchangeability must be established for every condition of use for which the reference product is licensed, regardless of whether the biosimilar applicant intends to label its product for every such condition. AbbVie asks the FDA to “clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity.” Petition at 1. Finally, AbbVie requests that the FDA convene a Part 15 hearing to receive public comment and then issue guidance on the issue. Read the rest of this entry »

Posted on Friday, December 11 2015 at 8:58 pm by
Amgen v. Apotex: 180-Day Advance Notice of Biosimilar Marketing is Mandatory

By: Alyson L. Wooten, Pharm.D. and Carolina M. Wirth

The Federal Circuit in July said in its Amgen-Sandoz decision that declining to share information under the biosimilars pathway “patent dance” made the 180-day advance-notice provision mandatory;1 however, it left open the possibility that agreeing to share information made the 180-day advance-notice provision optional. This week a Florida Federal District Court judge slammed the door on this possibility for Apotex in its biosimilar application for Neulasta® (pegfilgrastim).2 U.S. District Judge James I. Cohen found that notice is in fact always mandatory, concluding that optional compliance would “result in confusion and uncertainty, as well as inconsistent results, depending on which route a [biosimilar] applicant chooses to travel.” This is the first post Amgen-Sandoz decision further interpreting the patent disputes resolution procedures under the Biologics Price Competition and Innovation Act (BPCIA). If the District Court’s interpretation of the Affordable Care Act’s biosimilars pathway stands, the 12-year marketing exclusivity granted to brand-name biologics under the BPCIA will be extended by six months. Thus, as some have argued,3 resulting in a period of exclusivity longer than that intended under the BPCIA. Read the rest of this entry »