In March 2021, researchers from Harvard Medical School, Harvard University, and Brigham and Women’s Hospital published a white paper exploring the link between entry of biosimilars under The Biological Price Competition and Innovation Act (BPCIA) and moderation in drug prices driven by market competition. The white paper studied the price and…
The Senate passed a bill (S. 164) earlier this month (on March 3, 2021) “[t]o educate health care providers and the public on biosimilar biological products, and for other purposes.” The proposed “Advancing Education on Biosimilars Act of 2021” would add a section to the Public Health Service Act on…
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order: 1. Pfizer Announces Launches and Pricing Information for Three U.S. Biosimilars In January, Pfizer announced that it has launched three new…
As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory, market, and legal developments impacting biosimilars. We start today with our picks for…
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 was being developed through Archigen Biotech, a joint venture with AstraZeneca. According to a report in Korea Biomedical Review, a Samsung Biologics…
The results of a survey of board-certified rheumatologists in the United States about their beliefs and knowledge regarding biosimilar products were recently published in the journal Rheumatology. The online survey was conducted in May 2019 and included 19 multiple-choice questions assessing respondents’ knowledge of concepts and terminology concerning biosimilars, availability…
On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. According to Lotus’ press…
IP Litigation Partner and BMW editor, Bill James will be part of the Pre-Suit Exchanges and the BCPIA Tango discussion panel at the Summit on Biosimilars & Innovator Biologics presented by the American Conference Institute, Sept 23 -24. To register please click here.
As biosimilars begin to gain traction in the U.S. pharmaceutical market, the distinct labeling requirements applicable to them are likely to affect product liability litigation in this area, raising implications that are potentially distinct from those applicable to biologics and to small-molecule, generic drugs write Products Litigation and Counseling lawyers…
Last week it was announced that Coherus BioSciences’s pegfilgrastim biosimilar Udencya would be excluded from Express Scripts’s preferred formulary starting January 1, 2021. The pharmacy benefit manager’s preferred Neulasta biosimilars for next year are Mylan’s Fulphila and Sandoz’s Ziextenzo.