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With a number of branded biologics hanging at the patent cliff, the future looks promising for biosimilars.

Biosimilar Development: 10 Years On

Virginia Acha, DPhil, is director of regulatory policy, Europe, Middle East and Africa, at Amgen.

To realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.

Emerging Opportunities with Biosimilars

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

FDA Accepts First Biosimilar Filing

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

FDA Urged to Preserve Biosimilar Naming Conventions

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

Research Firm Predicts Negative Impact of Biosimilars

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA Releases Draft Guidance on Biosimilarity

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.

Gallus BioPharmaceuticals Uses ambr15 Micro Bioreactor to Develop Novel Antibodies and Biosimilars

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.

Nanosimilars and follow-on nanomedicines

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

A Survey of Postapproval CMC Changes to Generic Drugs

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.