A Watershed Year for Biosimilars in the U.S.

Increasing access to generic and biosimilar medicines will strengthen our nation’s economy while improving patients’ access to the medicines on which they rely.

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In a 49-page brief (PDF) filed with the Supreme Court, the Biosimilars Council took issue with the U.S. Federal Circuit’s ruling that would give branded drugmakers an additional six-month reprieve before a biosimilars launch.

Watch the full video of The Atlantic event, which gathered key stakeholders to examine the future for biosimilars domestically and abroad.

Having more biosimilars in the US would be a big deal: It might be the best way to drive down the cost of biologic medications that have been around for a while. The savings of putting people on far less costly biosimilars — even just new patients who have never taken the original — are estimated to be billions of dollars.

Biosimilars offer the potential for tens of billions of dollars in patient, insurer and health system savings, but only if patients can access them in a timely manner — as Congress directed.

The Supreme Court’s decision today is a huge victory for American patients and consumers,” said Chip Davis, President and CEO of the Association for Accessible Medicines (AAM). “This ruling will help provide faster access to lower-cost biosimilar medicines for millions of patients facing diseases such as several forms of cancer, rheumatoid arthritis, psoriasis, multiple sclerosis, and other life-threatening conditions.

New research from Avalere found that most health plans are covering at least one of the two biosimilar products currently on the market.

Faced with competition, some pharmaceutical companies are cutting deals with insurance companies to favor their brand-name products over cheaper generics. Insurers pay less, but sometimes consumers pay more.

Over Humira’s lifetime, AbbVie has secured more than 100 patents to prevent anyone from attempting to copy the biologic, with $16 billion in annual sales.

The US Biosimilars Council praised the WHO move, which follows the US Food and Drug Administration’s (FDA) use of a system in which biosimilar nonproprietary names come with a four-letter suffix to distinguish them from their reference products, which is similar to what WHO had proposed.

The Biosimilars Council, which represents biosimilar makers, praised the CMS decision, citing an analysis that separate codes would save the federal government $11.4 billion over the next ten years.

PhRMA is fighting the use of biosimilars using the same tools they used to fight generics in the 1980s – legal challenges and dissemination of clinical misinformation.  And just like generics, switching to biosimilar drugs is the one of the most effective ways to reduce overall drug costs.