Business

The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.

Catherine Swick, MBA, senior vice president of Provider Strategy and Marketing at McKesson, discusses efforts to get oncology biosimilars into play at US Oncology Network.

Chad Pettit, MBA, executive director of Marketing and the Global Biosimilars commercial lead for Amgen, discussed the company’s 2021 Biosimilar Trends Report and his projections for the future of the biosimilars market.

Passage of HR 3 is shaping up as a centerpiece of President Biden's effort to bring pharmaceutical prices under control. If drug companies won't negotiate prices, international reference pricing would kick in.

Health care systems need to consistently reevaluate whether the biosimilars they utilize are the most cost-effective, Neal Dave, PharmD, the executive director of pharmacy at Texas Oncology, explains.

When it comes to exports, Celltrion Healthcare leads the way among Republic of Korea pharmaceuticals producers. The company's biosimilars are the leading exports.

Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate.

On this week’s episode of Not So Different, we spoke with David Senior, senior vice president of Market Economics at AmerisourceBergen, about the development of the generics market and how this could be instructive in understanding how biosimilars sales may develop.

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.