Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics. Insulin As we previously reported, Biocon and Mylan are collaborating in the development of a follow-on product to Sanofi’s LANTUS (insulin glargine). On February 22, 2020, Biocon announced that the U.S. FDA had conducted…
Today, the Federal Circuit issued a Rule 36 affirmance of the district court’s judgment of non-infringement in the litigation involving Celltrion’s infliximab biosimilar. The court heard oral argument in the appeal yesterday. As we previously reported, Janssen had appealed the district court’s order granting Celltrion’s motion for summary judgment of non-infringement of…
We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar of EPOGEN. Last week, Amgen filed its response. As background, in December 2019,…
We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Yesterday, a Federal Circuit panel (Judges Prost, Wallach, and Bryson) heard argument regarding on Genentech’s appeal. The argument, much like the appellate briefing, focused on the issue…
Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with a user fee goal date of December 27, 2020. Mylan is the fourth biosimilar developer to report the filing of…
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). In recent weeks, several biosimilar developers have…
On Feb. 13, 2020, the European Medicines Agency (EMA) granted market authorization for Amsparity, Pfizer’s adalimumab biosimilar. Amsparity is approved for use in treating the same set of conditions as Humira in Europe. In 2018, Pfizer announced that it had reached a license agreement with AbbVie that allowed Pfizer to…
On February 21, the FDA published a final rule in the Federal Register that implemented a requirement of the BPCIA, transitioning insulin, and some other products such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropinalfa, and menotropins, from regulation as small molecule drugs to biologics. With respect to insulin,…
The FDA recently issued a final rule regarding the definition of “biological product,” amending its previous definition. The statutory definition of “biological product” included “protein (except any chemically synthesized polypeptide),” but this past December Congress removed the parenthetical excluding “any chemically synthesized polypeptide.” Now, the FDA has announced that it…
Today the FDA launched a partial searchable version of the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”, colloquially known as the “Purple Book“. According to the FDA’s press release, the Purple Book is now available both as lists and a searchable, online database. …