As we’ve previously reported, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants, and several other entities subsequently submitted comments on AbbVie’s petition. On December 1, 2015, FDA issued an interim response to AbbVie’s petition indicating that “FDA has been…
On December 4th, Amgen submitted a Marketing Authorization Application to the EMA for a biosimilar candidate (ABP 501) to Humira (adalimumab). Adalimumab is an anti-TNF-α human monoclonal antibody (the first approved by FDA) and is used to treat disorders such as rheumatoid arthritis and Crohn’s disease. This is Amgen’s first…
On November 20th, the U.S. Department of Health and Human Services (HHS) held a forum entitled “HHS Pharmaceutical Forum: Innovation, Access, Affordability and Better Health.” A list of the speakers and their biographies is available here, and a link to video recordings of the proceedings is available here. The forum…
On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. This is the second biosimilar antibody drug that…
Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab). As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. Sandoz, Amgen v. Hospira, and Amgen v. Apotex. This is the first time Amgen has formally appeared on…
As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…
As we’ve covered previously (here and here), Amgen has moved for a preliminary injunction to prevent Apotex from launching its biosimilar version of Amgen’s Neulasta until at least 180 days after FDA licensure of Apotex’s product. In its reply to Apotex’s opposition to its motion for a preliminary injunction, Amgen reiterates its…
The TPP agreement was reached on October 5, 2015, and the full text of it was released on November 5, 2015. But it hasn’t become law yet in the U.S., and may not for some time. What are the various requirements needed before the TPP can be finalized as law?…
Yesterday, Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim). This is the second of ten proposed regulatory filings Sandoz has promised to make over the next three years (the first of which is…
On Friday, November 16, 2015, Apotex filed its brief in opposition to Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed previously here, Amgen has moved to enjoin Apotex from marketing its yet-to-be-approved Neulasta biosimilar until at least 180 days after FDA approval. Amgen has taken…