Generic Drugs

A GPhA report says generic drugs saved the US health system $239 billion in 2013.

A surge in generic drug applications is testing FDA?s ability to reduce the backlog of ANDAs.

Concerns about quality in overseas production may bring generic drug production back to the United States, concludes CPhI study.

The European system for assessing drugs will be used as a model internationally.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

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

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.

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.

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

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

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

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.

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.

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

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

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

BioOutsource will open a new Biosimilar Center of Excellence in Scotland.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

FDA and EMA launch initiative to share bioequivalence inspection information.

Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates.

OGD is under pressure to improve review operations.

Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

Jill E. Sackman, D.V.M., PhD, senior consultant at Numerof & Associates, Inc. discusses the market forces impacting biopharmaceutical manufacturing

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

Unilife to begin commercial supply in 2014.

Generic Drug Super Office Takes Shape

Governor Jerry Brown cites physician notification requirements for dispensing biosimilars as premature in the absence of FDA specifications for interchangeability.

Industry experts discuss the importance of characterization studies during biosimilars development and related analytical methods.

Hospira's Inflectra (infliximab), which is a biosimilar to the reference biologic product, Remicade, has been approved by the EC for the treatment of inflammatory conditions.