Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.
Innovent and Eli Lilly have announced final clinical results for their sintilimab plus bevacizumab biosimilar injection, which has been accepted by China’s National Medical Products Administration (NMPA).
The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ (Amneal) bevacizumab biosimilar, Alymsys, the third bevacizumab biosimilar to be approved in the US.
Avsola (ABP 710) is a biosimilar to the infliximab reference product (Remicade), a monoclonal antibody targeting tumour necrosis factor-alfa. Avsola is approved in the US and Canada for all the same indications as Remicade, including adult and paediatric Crohn’s disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis [1, 2]. Infliximab is a highly efficacious treatment for inflammatory bowel disease (IBD), which includes CD and UC. The totality of evidence (TOE) supporting the development and approval of ABP 710 was recently reviewed .
Marín-Jiménez I et al. published in April 2021 a report based on a survey that was launched in Spain between June and November 2020 among hospital pharmacists and specialty physicians (dermatology, rheumatology, gastroenterology) to analyse knowledge, perceptions, attitude, barriers and facilitators of biosimilars uptake. Response rate was close to 100%.
On 28 March 2022, the European Commission (EC) has granted marketing authorization for Fresenius Kabi's oncology biosimilar, Stimufend (pegfilgrastim); and the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2022 that it had recommended granting of marketing authorization for an insulin aspart biosimilar and an insulin human (rDNA) biosimilar.
Amgen has announced positive results from a phase III trial of its ustekinumab biosimilar, ABP 654. The trial met its primary endpoint, demonstrating no clinically meaningful differences with the originator product, Stelara.
In March 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced that it will launch a study on biosimilars use and spending trends in Medicare Part B. The US Food and Drug Administration (FDA) has also made changes to clinical trials to improve information available on use of biosimilars in older patients.
A report from the American Enterprise Institute (AEI) suggests that regulating drug prices in Medicare is unlikely to lead manufacturers to compensate by increasing revenues from the commercial market, based on analysis of similar events in the European Union (EU).
Rani Therapeutics and Progenity have announced the respective launch and development of new oral, needle-free methods to deliver large biological drug molecules.