In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer. AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes…
On May 6, 2020, Bausch + Lomb and co-development partners STADA and Xbrane announced that they have entered into an exclusive licensing agreement with one another under which Bausch + Lomb will commercialize Xlucane, STADA and Xbrane’s proposed biosimilar of LUCENTIS (ranibizumab), if approved, in the United States and Canada….
On April 30, 2020, Sanofi received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP), recommending the granting of marketing authorization for its biosimilar of insulin aspart (NovoRapid, marketed by Novo Nordisk). Insulin aspart is a fast-acting insulin analogue that is absorbed…
On April 28, 2020, the U.S. Patent and Trademark Office (USPTO) issued a notice to extend certain patent and trademark deadlines to June 1, lengthening extensions that the USPTO had announced on March 31. Pursuant to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), certain deadlines between March…
We are pleased to present the second in a series of webinars relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S. which provides expert guidance and practical know-how for lawyers working in this growing area of the law. The second webinar, Biosimilars Patent Challenges At The PTAB,…
Teva and Celltrion Healthcare announced today the U.S. launch of TRUXIMA® (rituximab-abbs) for rheumatoid arthritis (RA). TRUXIMA®, which originally launched in November 2019, is now approved to treat RA, non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyaniitis (MPA) in adult patients. …
An April 2020 article in Arthritis & Rheumatology by Joshua F. Baker et. al. reported the results of a cross-sectional study comparing uptake in the ordering of biosimilars at two medical centers in Philadelphia: the University of Pennsylvania Health System (“UPHS”) and the local Veteran’s Affairs medical center (“VMAC”). The…
As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their “collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and…
On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals. At the PTAB, Pfizer had challenged the validity of Chugai’s patents (7,332,289 and 7,927,815) covering processes relevant to the manufacture of rituximab. In support…
Last week, Amgen filed a new complaint against Pfizer and Hospira under the BPCIA for infringement related to Hospira’s filgrastim biosimilar. The action is related to newly granted U.S. Patent No. 10,577,392, which is directed to methods of purifying proteins used in the manufacture of a biological product. The complaint…