Amneal announced today that the U.S. Food and Drug Administration has approved its Biologics License Application for FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing NEULASTA®. FYLNETRA, developed in collaboration with Kashiv Biosciences, LLC, is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which…
Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year. As reflected by the assumption in the Company’s Full Year…
On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…
Amneal Pharmaceuticals, Inc., a fully integrated pharmaceutical company headquartered in Bridgewater, NJ, announced last week that the U.S. FDA has accepted its aBLA seeking approval of a biosimilar of Avastin® (bevacizumab). This biosimilar was developed in collaboration with Spain-based biopharmaceutical company mAbxience, which had obtained approval earlier this year to…
On April 5, 2021, , Inc. (“Amneal”) and Kashiv BioSciences LLC (“Kashiv”) announced that Amneal’s wholly-owned subsidiary, Amneal Pharmaceuticals LLC, has completed its acquisition of a 98% interest in Kashiv’s wholly-owned subsidiary, Kashiv Specialty Pharmaceuticals, LLC (“Kashiv Specialty”). According to the release, Amneal has a portfolio of more than 250…
As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…
In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for a biosimilar of Neupogen® (filgrastim). In October, Amgen filed an amended complaint, reducing the number of asserted patents to four,…
Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. announced today that they have completed their business combination to form Amneal Pharmaceuticals, Inc. (“Amneal”). According to the press release, with the completion of this business combination, Amneal is now the 5th largest generics business in the United States. Amneal also states that,…