In honor of Women’s History Month, Big Molecule Watch recognizes Brigitte “Ita” Askonas, widely regarded as the mother of modern immunology. Born one hundred years ago, Dr. Askonas contributed to our understanding of the origin and synthesis of antibodies and the body’s immune response. In 1952, she joined the National…
On December 9, 2022, Biogen announced that the FDA has accepted for review an aBLA for BIIB800, Biogen’s tocilizumab biosimilar candidate. BIIB800 references Genetech’s ACTEMRA product, which is an anti-interleukin-6 receptor monoclonal antibody indicated for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic…
Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States: ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech’s AVASTIN product. ALYMSYS is a vascular endothelial growth factor inhibitor approved by the FDA in April 2022 for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent…
On July 26, Prestige Biopharma Limited (“Prestige”) announced a partnership with Intas Pharmaceuticals Limited (“Intas”) and its affiliate Accord Healthcare to commercialize Prestige’s bevacizumab, HD204, a proposed biosimilar to Roche’s AVASTIN®, in the United States, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan, and…
The ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics will be held on June 28 – 29, to contemplate the details of the rapidly changing landscape for biosimilars and innovator biologics. Goodwin is a proud sponsor of the conference and, Goodwin partner and Big Molecule Watch editor, Huiya Wu is a…
Big Molecule Watch honors Women’s History Month by recognizing the women who have contributed to the advancement of biologics and biosimilars. We highlight one such individual, Rosalyn Yalow, who received a Nobel Prize for Physiology or Medicine in 1977 for her work on radioimmunoassay. Dr. Yalow, together with her research…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). Humira® is approved to treat certain inflammatory conditions. Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s…
On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions that charge various agencies with tasks to promote generic and biosimilar competition. The Order directs the Food…
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…
Further to our post last week on British Columbia’s policy requiring “switching” patients taking Humira, the Alberta government has also implemented a policy, effective May 1, 2021, of requiring that patients over the age of 18 taking Humira switch to one of five adalimumab biosimilars approved by Health Canada: Amgevita, Hadlima,…