Rheumatology

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.

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.

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.

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

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

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.

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.

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.

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

"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.

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

Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues.

Key 2020-2021 updates to the Guide to Biosimilars litigation and Regulation in the US encompass antitrust litigation, preliminary injunctions, and a slowdown in litigation.

Minnesota legislators introduce what could possibly become the first law to curtail payers' rights to determine which biologics patients have access to.

Investigators evaluated trial spending and reasons for biologics license application failures.

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.

Robidoux's reelection comes as biosimilars get a lift from automatic switching policies in British Columbia and Alberta.

Anar Dossa, director of Pharmacy Services at Pacific Blue Cross, discusses the company's involvement with British Columbia's biosimilars switching program.

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.

Gary H. Lyman, MD, PhD, provides an expert overview on overcoming the challenges of discussing biosimilars with patients.

We sat down with Sarfaraz Niazi, PhD, an adjunct professor and biosimilar industry expert, to discuss the potential impact high-concentration adalimumab products could have on the US market.

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

Biosimilar availability will expand treatment of rheumatoid arthritis (RA) to more patients and earlier disease settings, so it's important to understand the potential complications.

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