Regulatory

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

During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for tailored approach to bring biosimilars to market sooner with less expense and wasted effort.

Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.

Maria Manley, LLM, a life sciences expert and London-based partner with Sidley Austin, provides a deep-dive look at the complexities of Brexit and how it is likely to challenge the biologics industry.

The anatomy of an interchangeability switching study.

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

Representative Carolyn B. Maloney, D-New York, questions the use of pharmaceutical profits to defend against biosimilar competition.

Biocon tests the waters with itolizumab in pandemic-ravaged India, and Celltrion announces early success with an agent for the South African variant.

How much muscle did Congress invest in a pair of bills recently signed by President Biden? The answer may lie in your willingness to believe.

The European Union is a diverse market with pockets of biosimilar resistance but also cost-saving triumphs, panelists said at the Biosimilar Medicines Virtual Summit 2021.

Russia's land area is vast relative to its population, but Prestige Biopharma eyes an ample market for its bevacizumab biosimilar candidate (HD204).

US senators hope to spread the word about biosimilars and limit product exclusivity protections to those products that truly deserve them.

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

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.