Regulatory

This is the second of a 2-part series on a study from the independent research center NORC at University of Chicago concerning biosimilar acceptance and uptake.

Shanghai Henlius Biotech says the market for a checkpoint inhibitor in China is wide open, and Biogen and Bio-Thera stake out a global map for their tocilizumab biosimilar.

To overcome provider and patient preferences for brand originators, there has to be more of an incentive to use biosimilars, explains Nedzad Pojskic, PhD, MSc, Green Shield Canada.

An internationally recognized authority on biosimilar development discusses varieties of copy biologics in India and the need to distinguish these from true biosimilars.

The latest e-book from The Center for Biosimilars® offers insightful content on patient education, biosimilar development, and regulatory issues.

Calls for price regulation and lopsided incentives are threats to biosimilar progress, Community Oncology Alliance (COA) Executive Director Ted Okon argues.

Richard G. Frank, PhD, and Meaghan Rose Smith discuss a recent white paper on the regulatory and anticompetitive impediments to biosimilar market entry and the hope for biosimilar savings.

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.

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.

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.

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.

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

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.

"Shocked" by the threat of competition, originator manufacturers start raising prices long before rival products appear on the scene, investigators found.

Alvotech closes on $35 million in funding, and Samsung Bioepis gets closer to marketing an adalimumab biosimilar. Alvotech's planned high-tech expansion is pictured.

State Representative Jennifer Schultz (D, Duluth) explains how her bill requiring payers to cover all approved biosimilars and reference products would save money and improve access.

The Senate has passed a bill requiring the FDA to provide educational information that supports and promotes the adoption of biosimilars.

The Biologics Price Competition and Innovation Act has been around for 10 years, but grey legal areas still abound, Goodwin attorneys note.

Lannett modifies a pivotal trial design to ensure a smoother ride through the FDA product review.