What legislation allowed approval of biosimilar products?
Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product.
Does the Commonwealth of Massachusetts have any laws or regulations relating to biosimilars?
The Massachusetts Biosimilars Act c. 112 § 12D (“Section 12D”) to substitute generic drugs for prescribed branded drugs. As noted above, the Act establishes five requirements that must be met in connection with the substitution of an interchangeable biosimilar.
Are biosimilars legal?
Biosimilars in the U.S. At present, there are only four FDA-approved biosimilars available (TABLE 2), although many others are in development. None of these agents is currently approved as an interchangeable product.
How are biosimilars approved by FDA?
According the to FDA, biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
What is the purpose of a biosimilar?
Biosimilars use the exact same starting materials and similar manufacturing processes as the original biologic. They are designed and developed to be highly similar to the original drug upon which they are based, and they will not be approved as a biosimilar if they are not.
Can pharmacists substitute biosimilars?
Allows a pharmacist to substitute an interchangeable biosimilar product for a prescribed biosimilar product if the prescriber and patient are notified; and the prescribing practitioner has signed “May substitute” on the prescription.
Can biosimilars be patented?
In general, biologic medicines and biosimilars are patentable in India subject to certain exceptions governed under Section 3 of the Patents Act (for biosimilar patents Subclauses (b)-(e), (h)-(j) and (p) are of particular relevance).
How many biosimilars have been approved by the FDA?
FDA has approved 33 biosimilars corresponding to eleven different reference products.
Is Remicade a biosimilar?
The FDA approved RENFLEXIS as biosimilar to Remicade. This means that RENFLEXIS acts in a similar way to Remicade, and there are no clinically meaningful differences in effectiveness and safety. Your treatment routine stays the same. RENFLEXIS works like Remicade.