On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA). RIABNI has been approved since December 2020 for treatment of adult patients with…
Earlier this week, Shanghai Henlius Biotech, Inc. announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay S.R.L. for the commercialization of HANLIKANG (rituximab) and HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), two products developed by Henlius, in Brazil. According to the announcement, Abbott will pay…
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…
Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…
This week, IQVIA released an independent report on its research into the current state of the biologics market in the United States. IQVIA, formerly Quintiles and IMS Health, Inc., is a contract research organization serving the combined industries of health information technology and clinical research. In an overview of the…
On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc. That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…
Today, Cadila Pharmaceuticals announced the launch of its adalimumab biosimilar, Cadalimab™, in India. HUMIRA® (adalimumab) is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis. Cadila’s press release noted that “[i]n an effort to strengthen their biosimilar product portfolio, Cadalimab™ is the fourth biosimilar launched in the last…
Shanghai Henlius Biotech, Inc. announced on August 14, 2020 the approval of its trastuzumab biosimilar HLX02 by the National Medical Products Administration (NMPA). This same product was approved by the European Commission on July 27th. According to the press release, this is the the first China-developed mAb biosimilar to be…
On July 29, 2020, Cadila Pharmaceuticals announced its launch of Rituximab biosimilar Ritucad for the Indian market. Rituximab is used to treat certain types of blood cancers and rheumatoid arthritis. Ritucad was the Indian pharmaceutical company’s second biosimilar launch in July. On July 22, 2020, Cadila announced the launch of…
As we previously reported, Genentech and JHL Biotech reached a settlement agreement resolving the parties’ lawsuit regarding JHL’s alleged misappropriation of trade secrets relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme® (dornase alfa) products. However, the case continued against the four former Genentech employees as individual defendants, although…