News

PlantForm will use tobacco plants to develop antibodies for its checkpoint inhibitor pembrolizumab biosimilar.

Shanghai Henlius Biotech began as a 2-person enterprise in 2010 and now has multiple oncology products in development and 3 biosimilars on the market. An executive discusses its business trajectory.

India has tightened up guidelines for biosimilar development in a quest to achieve standards equivalent to those in Europe and the United States.

Maria Manley, LLM, a life sciences expert, talks about how the United Kingdom’s exit from the European Union has changed the regulatory landscape for biologics.

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, recounts a debate with a young clinician over the reliability of biosimilarity testing.

Seeking to develop a biosimilar portfolio, Stada Arzneimittel has launched Oyavas in Germany and the Netherlands.

Here are the top 5 biosimilar articles for the week of March 29, 2021.

The month of March brought intense debate and legislative action over biosimilar policies.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a thumbs up for a subcutaneous (SC) infliximab biosimilar candidate from Celltrion.

Insulin is not a complex drug, but churning it out in massive quantities at high levels of purity is one of the main hurdles inhibiting biosimilar competition, panelists said.

Potential developers of orphan drug biosimilars face daunting challenges to get these drugs approved and onto market, said a panel of experts.

Regulators want built-in flexibility, and that benefits biosimilar developers, but there can be a price for this amount of latitude, panelists said.

Through a partnership with Merck, Samsung Bioepis adds to its portfolio of biosimilars available in Australia.

Juliette Petit, MD, a French rheumatologist, talks about her recent study showing that nurses can help curb patient fears and prevent a possible nocebo effect when switching them to a biosimilar.

EirGenix, in partnership with Sandoz, announced positive safety and efficacy results for its trastuzumab biosimilar in patients with breast cancer.

A renowned expert on the life sciences industry in the United Kingdom provides an insightful look at Brexit and the importance for the pharmaceutical sector.

Here are the top 5 biosimilar articles for the week of March 22, 2021.

A panel of physicians gave advice on how biosimilar educational materials should instill confidence in these medications and which policies may be more harmful than beneficial.

The company claims in a suit that a former employee transferred high-concentration adalimumab trade secrets to his laptop and took those to a new job with Alvotech.

Biosimilars get short shrift in a proposed pricing model developed by the Drug Pricing Lab at Memorial Sloan Kettering (MSK), experts say.

Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently must be done to satisfy international regulatory requirements, investigators conclude.

Peter Bach, MD, MAPP, and his Drug Pricing Lab at Memorial Sloan Kettering (MSK) argue profit caps will do better than the current biosimilar system.

Biosimilars are intended to save money for the health care system, but for many reasons, they are not succeeding in this mission, Harvard authors argue.

Kenneth Komorny, PharmD, BCPS, was a co-lead on development of National Comprehensive Cancer Network (NCCN) recommendations for biosimilar management. He explains some of the positions the NCCN has taken.

Here are the top 5 biosimilar articles for the week of March 15, 2021.

Following lackluster experience with biosimilar marketing in the United States, Merck moves forward with spinoff plan.

Investigators observed early adoption of the trastuzumab biosimilar Kanjinti in patients with early breast cancer and metastatic breast cancer.

State Senator Carla Nelson explains how the pharmaceutical industry is reacting to her bill requiring payers to cover all approved biosimilars and reference products.

Pfizer said it has made a business decision to cease production of biosimilars at a $350 million plant it built recently in Hangzhou, China.

Coverage policies for biosimilars in the health care industry are the source of much angst.