Biosimilars and Biobetters

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications.

Innovator and generic-drug companies need to adapt to compete in the biosimilars market.

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.

The author provides an overview of QbD implmentation for biopharmaceuticals.

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.

Today begins the two-day public hearing being held at FDA headquarters in Rockville, MD, to gain public in put on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama's Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation.

Pfizer announced this his week that it had entered into a strategic global agreement for the worldwide commercialization with the Indian biotechnology company Biocon (Bangalore) for biosimilar versions of insulin and insulin analog products (e.g., recombinant human insulin, glargine, aspart, and lispro).

FDA to Hold Public Hearing on Biosimilars Legislation, And More.

The generic-drug company Actavis (Hafnarfjordur, Iceland) is considering acquiring a 51% stake in the biopharmaceutical company BioPartners Holdings (Barr, Switzerland) from Bioton, a Polish biotechnology company.

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasised the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonised, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasized the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonized, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

A Strengths, Weaknesses, Opportunities and Threats analysis of the biosimilars market is given.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

In light of the impressive size and predicted growth of the market, there has been a rising interest in the development of biosimilars.

Many hurdles lie between a biosimilar and success on the market. In particular, there are three main questions that companies will be asking themselves.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

Last year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products.

The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.

We speak to The European generic Medicines Association about the environment for biosimilars.

The EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

Analysis of the opportunities and challenges in the biosimilars market.

BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.

Follow-on biologics or biosimilars offer a niche growth market for the pharmaceutical industry. As the process for establishing a regulatory pathway for biosimilars is debated, companies, including Big Pharma, are positioning themselves to gain this piece of the pharmaceutical pie.

A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week.

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.