FDA releases plan to boost biosimilars development
The US Food and Drug Administration (FDA) has announced new measures to advance the development of biosimilar medicines.
In a statement released yesterday, December 11, FDA commissioner Scott Gottlieb announced the publication of four guidance documents on the organisation’s biosimilars policy framework.
The FDA licensed a record seven biosimilars in the past year, Gottlieb said.
The measures will also see some medicines currently licensed as drugs, such as insulin, be re-classified as biologics. These changes will come into effect in March 2020, opening these drugs “up to competition through the biosimilars pathway”.
There is currently no generic insulin product on the market. Gottlieb said he was confident that biosimilar insulin products will be attainable under the new regulations, describing it as a “watershed moment” for the millions of patients in the US who require regular insulin.
In the statement, the FDA clarified that products re-classified as biosimilars will not receive the 12-year exclusivity period afforded to newly licensed biologics. Rather, Gottlieb said, once the patent and previously granted protections have lapsed, these drugs will “be open to brisk competition from biosimilars”.
“The new pathway we’re laying out today should help usher in a new era of competition for these products that’ll lead to lower prices and better access,” the statement said.
One of the key priorities highlighted in the statement was improving access to reference samples for companies seeking to produce biosimilars. Gottlieb accused some pharmaceutical companies of engaging in “anti-competitive” behaviour.
The FDA will now clarify the terms of a drug’s Risk Evaluation and Mitigation Strategy (REMS) to ensure it does not inhibit access to reference samples for testing. A REMS sets conditions or guidelines on the use of a drug, such as ensuring that it is “administered only in certified healthcare facilities”.
A biosimilar must be tested against a reference sample of the original drug. Gottlieb said some companies are exploiting the REMS to prevent the development of biosimilar competitors by withholding reference samples. He added that the FDA was “not going to be partners to these deceptions”.
Under the new measures, the FDA will write to the reference product owner informing it that supplying sufficient quantities of the product for testing will not violate the terms of the REMS. This is conditional on there being comparable safety protocols attached to the testing samples as those in the product’s REMS.
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