A bipartisan group of Congressional representatives have introduced legislation that would open the door to “follow-on biologics” or “biosimilars,” copycat version of complex molecules that make up biotechnology products. Driving the legislation is the promise of billions of dollars in savings as the federal government seeks to cut spending on healthcare and increase access to life saving medications to patients who might not be able to afford them. But industry advocates warn that as written, the proposed legislation “jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases.”

 

Reps. Henry Waxman (D-California), Frank Pallone (D-New Jersey), Nathan Deal (R-Georgia), and Jo Ann Emerson (R-Missouri) introduced the legislation dubbed the “Promoting Innovation and Access to Life-Saving Medicines Act.” The authors of the bill note that biotech drugs, while often life saving, are the fastest growing and most expensive components of the nation’s prescription drug bill. Many of them cost tens of thousands of dollars a year — prices that put them out of reach of many patients and impose an unsustainable burden on employers, insurers, and the federal government. The bill would give the U.S. Food and Drug Administration the authority to approve copies of biotech drugs and take steps to ensure that follow-on biologics are safe and effective.  The legislation has already won support from key business, labor and consumer groups.

 

“I believe this bill will lead to healthy competition and long-term savings for patients and payers, and will preserve innovation in the biotech marketplace,” says Rep. Henry Waxman, chairman of the House Energy and Commerce Committee. “Above all, this bill guarantees that the FDA has the scientific discretion to hold these drugs to the same high standard to which the original products are held. The only way we can succeed in establishing robust competition for biotech drugs is with biosimilar drugs that doctors and patients know they can count on.”

 

The biosimilar bill comes about a week after the reintroduction of patent reform legislation and as the Obama administration prepares for a full court press on healthcare reform setting biotechnology companies for a potentially tougher climate for drug development. The new landscape could stymie the industry’s ability to raise capital if investors find legislative changes are too onerous to make the high-risk investment in these companies attractive.

 

“We urge Congress to ensure that any pathway for approving biosimilars is grounded in sound science, safeguards patient safety, and preserves incentives to develop future breakthrough therapies and cures,” says Jim Greenwood, CEO of the Biotechnology Industry Organization.

The legislation would allow the FDA to approve biosimilars through an abbreviated application process. The makers of the biosimilars would need to demonstrate that there are no clinically meaningful differences between the biosimilar and the branded product. In addition, the legislation would require that the biosimilar producer show the two products are highly similar in molecular structure and share the same mechanism of action as the branded product, if known. The bill would also allow a product to show it is a “biogeneric” and establish it is interchangeable with the original product.  

 

But unclear in the legislation is to what extent biosimilar maker will have to put their copies of biotechnology products through clinical trials, a point of concern expressed by the biotechnology industry. Of concern too is the five years of market exclusivity the bill would provide to branded products. A modification of a previously approved product, under the bill, could provide three additional years of exclusivity, and one addition year if the drugmaker establishes that the product can be used for a new disease indication or conducts pediatric studies.

 

“The market exclusivity provisions in Hatch-Waxman have clearly demonstrated that we can achieve the much-needed balance between pharmaceutical competition and innovation for the benefit of consumers, payors and state and federal governments,” says Generic Pharmaceutical Association CEO Kathleen Jaeger, referring to the legislation that gave rise to generic drugs. “We’ve done it before with generics and we can do it again with biogenerics.”

But BIO’s Greenwood says the legislation fails to strike the necessary balance for patients or the economy. “Any biosimilars legislation must ensure safe and effective biosimilars, promote the continued development of new therapies and cures, and ensure the benefits of additional competition among biologics through the entry of biosimilars.”  

 

BIO has previously called for at least 14-years of data exclusivity for biologics, saying that “anything less could skew investment away from biologics research and development, jeopardizing the development of future pioneering biomedical advances.” However, the trade group voiced its support last year for legislation from Congresswoman Anna Eshoo, a Democrat from California, for the Pathway for Biosimilars Act. That legislation would provide 12 years of data exclusivity.

 

BIO officials say they expect Eshoo to introduce a competing bill on biosimilars as early as next week. They say it’s unclear how that will compare to her earlier version, but add that its likely be in line with what came previously and almost certain to be more favorable than the five years proposed in the current bill.