Biosimilars and Biobetters

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.

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Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.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

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.

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

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).

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.

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

Baxter and Coherus Biosciences colaborate to develop and commercialize a biosimilar version of etanercept for Europe, Canada, and, Brazil.

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

The companies initially focused on five biosimilar products.

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

Thomson Reuters released a report that provides a view of the challenges facing companies entering the United States biosimilar drug market.