We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie moved to dismiss Alvotech’s counterclaims and affirmative defenses of inequitable conduct, unclean hands, and patent…
On December 1, 2021 the government of British Columbia announced that it is further expanding its biosimilar initiative. The statement reported that as of November 30, 2021 an estimated 30,000 patients on the rapid-acting insulin lispro (Humalog) and insulin aspart (NovoRapid) would have six months to transition to the respective…
On November 25, 2021, Japan-based Mochida Pharmaceutical Co. announced that its adalimumab biosimilar, Adalimumab BS MA, had been launched in Japan following the listing of the drug on the National Health Insurance. According to the press release, Adalimumab BS MA is the first adalimumab biosimilar to Humira currently distributed in…
On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were invited to solicit scientific advice from regulatory authorities. In the European Economic Area (EEA), biosimilar approval requires applicants to submit…
The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL. The case had been administratively stayed since January 2020. Judgment…
Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. According to the press release, patients receiving sintilimab plus BYVASDA combined with chemotherapy (pemetrexed and cisplatin) demonstrated an improvement in progression-free…
July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
Ascletis Pharma Inc. (Ascletis) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announced that Ascletis’ subsidiary and Suzhou Alphamab have entered into an exclusive worldwide licensing agreement (excluding Greater China) for ASC22 (Envafolimab) to treat viral diseases, including Hepatitis B. According to the press release, ASC22, also known as KN035,…
On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab), which is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). Actemra® has been approved in the United States for the…