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Biosimilars

BioBytes: What are biosimilars?

Posted by ecreese on January 20, 2010 at 6:36am EST

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. However, there are a few important safeguards that must be put into place before these “similar but not the same” versions of biologics can be safely introduced to the public.  Join Dr.

Biologics bill will help make breakthrough drugs more widely available

Posted by nicoleatbio on December 7, 2009 at 10:36am EST

"As Congress has moved to overhaul the health care insurance industry in America, I've been struck by some of the myths put forward by opponents of the effort that have gained traction: death panels, government takeovers of health care, free care for illegal aliens and so on.

Meeting India's Biotech Community

Posted by Jim Greenwood on November 12, 2009 at 7:59am EST

Biotechnology is a global enterprise.  The United States continues to play the dominant role but European and Asian nations are continually expanding their capabilities. 

In preparation for BIO’s first ever partnering meeting in India in September 2010, I am travelling the subcontinent to promote the event and to assess the country's biotech capabilities and needs.

On November 4th in Mumbai, I visited Reliance Life Sciences which represents a huge investment in biotech from one of India’s largest and most well known companies.  Whil

Weekly Biotech Blog Roundup

Posted by nicoleatbio on October 23, 2009 at 10:42am EDT

This week we start with some healthcare information. Just about everyone is familiar with the healthcare reform issue. What they may not have heard of is a medicine called a biologic, and the debate over when should generic manufacturers allowed to make what are called biosimilars.

Weekly Blog Roundup

Posted by nicoleatbio on October 9, 2009 at 10:28am EDT

This week Health Reform Watch wonders if the biosimilars debate is over.

"Two months ago, I discussed possible federal legislation intended to balance the competing need for scientific and medical innovation with the costs to patients for biosimilars.

BIO Media Briefing: Healthcare Reform Should Preserve Innovation

Posted by stephanieatbio on September 11, 2009 at 9:11am EDT

BIO President and CEO Jim Greenwood and BIO Board Chair Dr. Stephen Sherwin discussed the need to ensure that health care reform promotes and preserves innovation, particularly in a pathway for biosimilars and the use of comparative effectiveness data.  Innovation also depends on a strong and predictable patent system, Jim explained.  Dr.

Jim Greenwood guest appearance on CNBC’s “Squawk Box” during this morning’s “Health Care Summit” special

Posted by susanatbio on August 13, 2009 at 5:32am EDT

BIO President and CEO Jim Greenwood joined former HHS Secretary Tommy Thompson and former FDA Deputy Commissioner Scott Gottlieb to discuss biosimilars and the importance of preserving innovation as the nation moves to reform our health care system.

Clearing Another Hurdle on the Pathway to Biosimilars

Posted by Jim Greenwood on July 31, 2009 at 2:12pm EDT

The House Energy and Commerce Committee, by a vote of 47 to 11, overwhelmingly adopted an amendment creating a regulatory pathway for biosimilars that will provide 12 years of data exclusivity for innovative biologics. The strong bipartisan support for this amendment to the America’s Affordable Health Choices Act marks the second win this month for a fair and balanced approach to biosimilars market entry.

This vote was a clear victory for patients.

Patient groups join call for data protection

Posted by Jim Greenwood on July 20, 2009 at 7:21am EDT

Biomedical innovation is not only key to our industry’s future, but more importantly, continued medical breakthroughs are vital to patients living with debilitating diseases and their families. Without ongoing progress in our industry, patients of today and tomorrow have limited hope for future cures and therapies.

Many patient groups have entered the debate on Capitol Hill over establishing a pathway for approval of biosimilars because they know how critical continued innovation is to finding new therapies and cures for diseases.

Victory on Biosimilars in Senate HELP Committee - But Still a Long Way from the Finish Line

Posted by Jim Greenwood on July 14, 2009 at 12:16pm EDT

Last evening the Senate Health, Education, Labor and Pensions (HELP) Committee adopted an amendment to the healthcare reform package that provided 12 years of data exclusivity for innovative biologics. This event was a significant victory for our companies and for patients. Two and a half years ago Senator Clinton and Congressman Waxman introduced bills that provided zero years of data exclusivity.

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