Business

Chad Landmon, JD, chair of Intellectual Property and FDA Practice at Axinn, Veltrop & Harkrider, provides a legal perspective on the implications of President Biden’s effort to improve the competitiveness of drug markets.

Ahead of receiving regulatory approval for a "wet" age-related macular degeneration biosimilar candidate, a broad-based commercialization deal is inked.

Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

Product differentiation, global partners, and a large suite of biosimilars in development are ways that Reykjavik, Iceland-based Alvotech expects to stay ahead of the competition.

China’s streamlined system for biologics approvals has enabled Shanghai Henlius Biotech to bring biosimilars to market faster and potentially at a lower cost, Ping Cao, vice president of Business Development, explains.

A second class of biosimilars that are considered "interchangeable" could set biosimilars back in terms of acceptance, according to Albert Kim, MBA.

After being sued for allegedly stealing adalimumab process information, Alvotech fires back.

Advances in analytical testing have improved confidence in biosimilars, according to a Medicines for Europe panel.

Biosimilar companies partnered with other companies and saw earnings increases, while reference product corporations faced sales erosion from biosimilar competition.

Allen Lising, managing director of Xcenda’s FormularyDecisions, explains how stakeholders are using pre-approval information to make business decisions.

More disclosures, earlier in the biosimilar application process, might lead to more competition in biologics, but panelists said this could go too far.

Opinions are diverse on how best to clear the obstructions to biosimilar market entry and patient access.

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

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.

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

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

Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, discusses motivating factors that affect use of biosimilars in oncology.

Lalan Wilfong, MD, an expert on value-based care, explains how Texas Oncology worked with physicians and payers to make biosimilars available for patients.

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.

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.

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.

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.

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.

Huiya Wu, JD, and Freddy Yip, PhD, PCLL, attorneys at Goodwin Procter, discussed biologic drug patent laws in China and the US.

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

We sat down with Steven Lucio, PharmD, BCPS, senior principal of Pharmacy Solutions for Vizient, to discuss Boehringer Ingelheim's recent citizen's petition to the FDA.