Effective 1 July 2019, the EU adopted a regulation by introducing a supplementary protection certificate (SPC) manufacturing and stockpiling waiver. This waiver also applies for biosimilar versions of SPC-protected medicine during the term of the SPC.
Read MoreThe U.S. Supreme Court unanimously decided Sandoz Inc., v. Amgen Inc., on Monday June 12, 2017, construing the Biologics Price Competition and Innovation Act (BPCIA). The Court held: (1) that the patent dance is not enforceable by injunction under Federal law, and (2) that a biosimilar applicant’s 180-day “notice of commercial marketing” can be provided before FDA approval. (See Sandoz Inc. v. Amgen Inc., Nos. 15-1039 and 15-1195, slip op. and our IP Alert Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument.)
The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi® and Amjevita®.
On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel®. The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA. Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions. Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.
By Naomi Pearce
FCA Confirms Commonwealth may Claim Relief Under “Usual Undertakings as to Damages”
The much anticipated Court of Appeal decision in Commonwealth of Australia v Sanofi ¹ was handed down on Monday. The decision is a win for the Commonwealth, and for generic/biosimilar companies in Australia, and (if upheld in any appeal) will result in Sponsors adopting a more circumspect approach to seeking interlocutory injunctions for patent infringement in Australia.
Except where a generic/biosimilar applicant has “cleared the way” (cleared any patent impediments to launch through the Courts in Australia) or all relevant patents have expired, interlocutory injunctions are routinely sought by the Sponsor, and are routinely granted.
On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA has adopted the same labeling approach as used for generic pharmaceutical drugs. However, AbbVie argues in its petition that “[b]iosimilars are not generic drugs and should not be labeled like generic drugs.”
To read the full alert, click here.
After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal Circuit in excluding the biosimilar from the market, at least temporarily. On May 5, 2015, the Federal Circuit granted Amgen’s motion for an injunction “preventing Sandoz [ ] from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until this Court resolves the appeal.” Amgen Inc. et al. v. Sandoz Inc. et al., Appeal No. 2015-1499, Dkt. 105 (Fed. Cir. March 27, 2015).
To read the full alert, click here.
In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the biological equivalent of the pharmaceutical Orange Book. See FDA Releases a Purple Book for Biosimilars. The Purple Book has now been updated to include Sandoz, Inc.’s (“Sandoz”), Zarxio® (filgrastim), the United State’s first biosimilar approved under the Biologics Price Competition and Innovation Act (“BPCIA”). See FDA Approves First Biosimilar: Sandoz’s Zarxio®.
To read the full alert, click here.
As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that the FDA mandate compliance with the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) information exchange provisions, often referred to as the “Patent Dance.” In particular, Amgen requested that the FDA require a biosimilar applicant to certify that it will timely comply with Section 351(l)(2)(A) of the BPCIA by providing the brand holder with a copy of the biosimilar application and information describing the process(es) used to manufacture the biosimilar product covered by the application.
To read the full alert, click here.
Sandoz Inc. filed the first biosimilar application under the Biologics Price Competition and Innovation Act on July 24, 2014 for a biosimilar version of Amgen Inc.’s Neupogen® (filgrastim). The FDA issued a Briefing Document for the Oncologic Drugs Advisory Committee Meeting held January 7, 2015 concluding that Sandoz’s biosimilar, referred to as EP2006 in the FDA’s Briefing Document, is highly similar to and has no clinically meaningful differences from Neupogen®.
To read the full alert, click here.
The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory judgment action due to lack of Article III jurisdiction. In particular, the industry has been waiting to see whether the Federal Circuit would uphold the district court’s ruling that Sandoz’s lawsuit was barred by the Biologics Price Competition and Innovation Act (“BPCIA”). Unfortunately, the Federal Circuit declined to address the district court’s interpretation of the BPCIA, providing no further guidance on the topic. Instead, the Federal Circuit simply affirmed the district court’s ruling that there was no subject matter jurisdiction, relying on Hatch-Waxman generic drug cases as precedent.
To read the full alert, click here.
Copyright © 2024, K&L Gates LLP. All Rights Reserved.