Manufacturing, Biosimilars and Biobetters

Understanding opportunities and challenges across all major phases of development.

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

Industry experts discuss significant achievements. Plus: What's in store for the future.

New outsourcing industry sectors have become multibillion-dollar industries.

Does global development have to entail multiple comparability studies?

Key business considerations when developing biosimilar products virtually.

How does working in a virtual biotech environment affect biosimilar development? Anjan Selz outlines target and partner selection in this first of a two part article.

Virtual biotech CEO Anjan Selz focuses on product development, credibility and differentiation.

Biosimilar manufacturers need better expression systems and analytical tools to compete.

The author explains the current status of India, the challenges, and recommendations that may alleviate these challenges.

Despite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs.

The market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.

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

Are biosimilars the next big thing or just the next big bubble?

Follow-on versions of complex biologics require extensive expertise.

So often a leader on the world stage, the US is a laggard when it comes to regulating follow-on biologics.

The third holy grail of biosimilars: interchangeability.

A single standard should apply to all comparability exercises for biologics, be they for biosimilars or manufacturing changes.

The new US legislation will forever alter the commercial landscape for biologics.

New R&D models must be tried, but it will take time to see if they work. In the meantime, a new kind of threat is on the horizon: biobetters.

Broader benefits and biosimilars will offset hefty fees and discounts while preserving R&D incentives.

The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion.

Ten biopharmaceuticals gained marketing authorization in the US or EU in 2008, although only four were new approvals.

The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC).

The Senate?s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee?s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday.

In advance of the Senate Health, Education, Labor, and Pensions Committee?s meeting to be held on Friday to consider amendments to the healthcare reform bill, including several amendments related to biosimilars, Biotechnology Industry Organization?s (BIO) President and CEO Jim Greenwood reaffirmed BIO?s support for a 12-year data exclusivity period for biologics.

The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.

A new report by FTC, entitled ?Follow-on Biologic Drug Competition,? examines whether the price of biologics is likely to be reduced by competition from FOBs.

To expand coverage amidst the economic crisis, Obama will be looking hard for ways to cut healthcare costs.