Regulatory

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.

Alteogen is among a number of contenders vying to bring aflibercept biosimilars to market. Key patents on the originator begin to expire in 2023.

Regulatory and launch news on rheumatology biosimilars for adalimumab and infliximab was plentiful in February 2021.

Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.

The National Comprehensive Cancer Network (NCCN) recommended providers contact their legislators to counteract single-biosimilar payer policies.

Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.

In a review of trastuzumab treatment options, reviewers concluded subcutaneous (SC) vs intravenous (IV) options may be more costly and sometimes less practical.

Sales of the pegfilgrastim oncology support biosimilar Udenyca fell off in late 2020, but Coherus doesn't see orginator company Amgen's advantage lasting much longer.

The Germany-based company with global operations plans to ramp up its biosimilars portfolio through 2025.

Huiya Wu, JD, and Freddy Yip, PhD, PCLL, attorneys at Goodwin Procter, discussed projections for the Chinese biosimilars market and the potential for foreign companies to get a share.

Fresenius Kabi steps into the Canadian market for adalimumab with Idacio.

Coherus BioSciences filed a 351(k) biologics license application (BLA) for CHS-1420, an adalimumab biosimilar candidate.

The launch of Hyrimoz gives Sandoz 5 biosimilars on the Canadian market. National policies on switching have given biosimilars a tailwind.

The marketing of Yuflyma is expected to give Celltrion Healthcare a significant advantage over existing adalimumab biosimilars.

Biosimilars, supply chain adjustments, building trust, and international standardization were discussed as means to deliver innovation when it's needed, not after.

The Bengaluru, India, company said the fast-acting biosimilar will improve affordability of insulin in Europe, which also faces rising prices and access problems.

Lannett and HEC Pharm are developing an insulin aspart biosimilar on the heels of their insulin glargine codevelopment project.

China’s regulatory reforms and policy enhancements bode well for a thriving biosimilars industry.