Manufacturing, Biosimilars and Biobetters

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Intellectual property lawyers estimate biosimilar litigation will swell as early as 2018.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Market forces may limit the success of CMOs.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

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

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

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.

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.

High technology assessments are having an impact on biosimilars development in Europe.

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

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).

USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.

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