Last week, Alvotech closed out the year with an announcement that it is expanding its high-tech center in Reykjavik, Iceland. This high-tech center, which will almost double the size of…
Last week, Alvotech closed out the year with an announcement that it is expanding its high-tech center in Reykjavik, Iceland. This high-tech center, which will almost double the size of…
Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid…
Samsung Biologics’ third quarter report disclosed that it had suspended its research and development of its SAIT101, a biosimilar of Rituxan. As we previously reported, the rituximab product…
In an effort to enhance development of medical products for orphan diseases (or rare diseases), the U.S. Food and Drug Administration announced on October 8, 2020 that it awarded six…
Celltrion announced last Friday that it will begin Phase I clinical trials of its Prolia (denosumab) biosimilar (CT-P41) in September. Prolia, marketed and sold by Amgen, is a treatment for…
Johnson and Johnson announced that it has entered into an agreement to acquire Momenta Pharmaceuticals, Inc. for $6.5 billion. The acquisition gives J&J’s Janssen unit full global rights to…
Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards. WHO prequalification status is based on an…
Yesterday, India-based Cadila Pharmaceuticals announced the launch of its bevacizumab biosimilar for the Indian market under the brand name BEVARO. Bevacizumab is a biosimilar of…
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…
This week, the U.S. Court of Appeals for the Federal Circuit issued two rulings in biosimilar-related appeals from final written decisions by the Patent Trial and Appeal Board (PTAB) in…