Author Archives: Sarfaraz Niazi

Biosimilars: Challenging the Justifications for Clinical Testing

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The Biologics Price Competition and Innovation Act (BPIA) of 2009, describes the need for clinical trials as follows (1): “(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.†However, all the above studies are left…

January 30, 2019

eBook: Challenges Facing Biosimilar Entries into US Markets

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Since the 2009 enactment of the Biologics Price Competition and Innovation Act (BPCIA) (1), the US Food and Drug Administration (FDA) has licensed six biosimilar products under PHS 351(k) and approved one product under FD&C 505 (b)(2). It also provided complete response letters (CRLs) to four biologics license application (BLA) filings (Table 1) (2). By comparison, the European Medicines Agency (EMA) has approved 31 biosimilar products (3) and refused or withdrawn about five. There is no doubt that US market…

January 16, 2018

Process Innovation Leads to More Affordable Biosimilars

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Biosimilars are set to dramatically improve how millions of people access expensive, complex, life-saving treatments by providing equally effective alternatives to innovator products while lessening the cost burden (>30%). Therapeutic Proteins International, LLC (TPI) is a fully integrated manufacturer of biosimilar recombinant protein products that has reinvented conventional approaches to biologic drug manufacturing. Powerful Science Shouldn’t Be Complicated TPI has reinvented the process used to manufacture biological drugs making it simpler by leveraging superior technology and rigorous scientific methods to…

August 15, 2014