On April 21, FDA approved Samsung Bioepis’ Renflexis, a biosimilar referencing Pfizer’s Remicade. Like Remicade, Renflexis is approved for the treatment of Crohn’s Disease (both pediatric and adult), Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis. Remicade was approved as an Orphan …
Well, that was quick! Only two weeks after filing, the U.S. District Court of Delaware dismissed Genentech’s Complaint under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen. As we explained here, Genentech sued Amgen for failure to comply with the patent dance provisions …
2017 is already shaping up to be a big year in court for Amgen and the Biologics Price Competition and Innovation Act (“BPCIA”). As regular readers know, Amgen’s challenge to Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on …
After months of promises and postponements, FDA has finally published its long-awaited draft guidance on biological product interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product, under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). While FDA had originally promised the guidance in …
We’ve previously posted some summaries of the 21st Century Cures Act (Cures Act), which the President signed into law on December 13, 2016 (Public Law No. 114-255). (Those summaries are available here, here, and here.) This post focuses on only one section of the new …
Way back in June 2016, the United States Supreme Court invited the Solicitor General to file a brief in two cases – Docket No. 15-1039 and Docket No. 15-1195 – expressing the views of the United States as to two provisions of the Biologics Price …
By Kurt R. Karst – Last Friday, FDA announced that the Agency licensed the fourth biosimilar biological product under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”): Amgen, Inc.’s (“Amgen’s”) AMJEVITA (adalimumab-atto) (BLA 761024), a biosimilar version of AbbVie Inc.’s (“AbbVie’s”) (BLA 125057) blockbuster …
By Kurt R. Karst – For several years now, the Obama Administration’s annual budget requests (here, here, and here, for example) have included proposals to reduce to 7 years the current 12-year period of Reference Product Exclusivity (“RPE”) for biological products licensed under Section 351(a) of …
By James E. Valentine & Josephine M. Torrente – In March, FDA published a draft guidance document that describes FDA’s approach to the implementation of the statutory provision in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an …
By James C. Shehan – FDA issued it second-ever approval of a biosimilar on Tuesday, April 5, giving the nod to Celltrion’s and Pfizer’s Inflectra, a biosimilar version of J&J’s Remicade (infliximab). The approval follows some of the precedents established in FDA’s approval of the first …
By James C. Shehan – On March 31, 2016 FDA released its promised guidance on labeling for biosimilar products. A few parts caught our eye, including another change of mind by FDA on the issue of whether a biosimilar’s labeling should identify itself as a biosimilar, The …
By James C. Shehan – On March 21, 2016, Amgen filed a brief opposing Sandoz’s request that the Supreme Court overturn last year’s Federal Circuit ruling that the Biologics Price Competition and Innovation Act’s ("BPCIA's") notice of commercial marketing provision is mandatory and can only be …
By James C. Shehan & Kurt R. Karst – On March 10, 2016, FDA released a draft guidance interpreting the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). This provision, at BPCIA § 7002(e)(4), is one of a …
By James C. Shehan – More than one commentator predicted that the Federal Circuit’s decision in Amgen v. Sandoz interpreting the patent dance provisions of the Biologics Price Competition Innovation Act ("BPCIA") would be a fertile source of new litigation rather than a definitive decision laying …
By Kurt R. Karst – Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating [Public Health Service Act (“PHS Act”) § 351(l)(8)(A) (42 U.S.C. § 262(l)(8)(A))] as a standalone requirement and creating an injunctive remedy that delays …
