Update on Biosimilars

Experts estimate that biosimilars could save consumers as much as $250 billion in the next ten years. This is expected to impact some of the most vulnerable patient groups including those with low incomes, senior citizens, and individuals with multiple chronic diseases by increasing accessibility and reducing out-of-pocket costs.

The goal for many is to streamline the barriers so biosimilars will get to market at a faster pace, However, so far, only five biosimilars have been approved by FDA to treat patients with conditions such as rheumatoid arthritis, Crohn’s disease, cancer, and psoriasis. .

A biosimilar product is a biological product that is approved based on showing that it is highly similar to an FDA approved biological product known as a reference product. A biosimilar product also has to show that there are no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Biosimilars continue to be a hot topic with policy and regulatory debates continuing in Washington. A patent case is in front of the Supreme Court and bills making their way through Congress may potentially change the market for biosimilars and the industry in general.

“The Atlantic” http://theatlantic.com has presented several programs on the subject of biosimilars. The first program held December 7, 2016 examined the emerging world of biosimilars and the regulatory framework in the U.S

On March 15, 2017, expert speakers discussed the need for more approvals for biosimilars. They want to streamline the approval process and achieve interchangeability since patients might be switched from one drug to another. For the Federal Telemedicine News article on the biosimilar conversation posted in March, go to http://federaltelemedicine.com/?=5477.

An update on biosimilars was presented by Atlantic LIVE on June 7, 2017 to discuss “The Next Drugs: An Atlantic Policy Update on Biosimilars”. Emily Akhtarzandi, Managing Director, AtlanticLIVE introduced Chester “Chip” Davis Jr, President and CEO of the Association for Accessible Medicines, speaking for the Biosimilars Council http://biosimilarcouncil.org. He explained that although the biosimilar development process is complex, companies that manufacture biosimilars are committed to providing safe effective products for patients.

Representative Peter Welch (D-VT) https://welch.house.gov discussed with Steve Clemons, Washington Editor at Large for “The Atlantic” ways to help consumers, Representatives Peter Welch and David McKinley https://mckinley.house.gov introduced the “Fair Access for Safe and Timely (FAST) Generics Act” to help bring down the cost for drugs. The legislation would increase consumer access to generic drugs, boost market competition, and ultimately save consumers money.

Representative Welsh in addressed biosimilars and the issue of patent protection and particularly the term “exclusivity” which is granted by FDA. FDA has issued guidance on biologics exclusivity by stipulating that the drug maker for a biosimilar has a 12 year marketing exclusivity period. Representative Welsh would like to see the market exclusivity period reduced from 12 years to 7 years.

Olga Khazan Staff Writer, for “The Atlantic” led a panel discussion on the patent landscape with Bruce Artim, Senior Director, Federal Government Affairs, Eli Lilly and Company www.lilly.com, Courtenay Brinckerhoff, Partner, Foley & Lardner LLP www.foley.com, and Phil Nickson, Associate General Counsel for Intellectual Property, Momenta Pharmaceuticals www.momentapharma.com,

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