The pipeline of follow-on (biosimilar) products in developmetn includes nearly 800 biosimilars. See Biosimilarspipeline
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (guidance by FDA)
Introduction:
Biosimilars are defined as “similar” or highly similar” to the reference medicinal products following the EMA (European Medicines Agency ) adn the US FDA regulatory guidielines. In 2012, the EMA issued guidelines on the development of biosimilar monoclonal antibodies. In 2012 the FDA released draft guidance for teh development and regulatory review of biosimilars. In India, the biosimilars are termed as “similar biologics” in accordance with the guidelines issued by the Central Drugs Standard Control Organization (CDSCO). (Bandyopadhyay “physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197, Biosimilars, 2015: 5, pp. 1-18).
The BPCA Act was enacted to establish an abbreviated pathway for FDA licensure of biological products that are demonstrated to be biosimilar to or interchangeable with an FDA licensed reference product.
Information Required in a BLA:
The sponsor of a proposed biosimilar product must, among other thigns, demonstrate that the proposed product is highly siilar to the reference product, notwithstanding minor didfferences in clinically inactive components, and that there are no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity and potency. A 351(k) BLA must contain, among other things, information demonstrating that the biological product is biosimilar to a reference product based upon data dervied from analytical studies, an assessment of toxicity, and clinical study or studies, unless the Agency determines, in its discretion, that an element described in section 351(k)(2)(A)(i)(I) of the PHS Act is uncessary in a 351(k) BLA.
Section 351 of the PHS act sets forthe the requirements for an applicant to demonstrate that biological product is biosimilar to a reference product.