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Biosimilars are highly similar versions of approved and authorized biological medicines. They are supported by rigorous analytical, non-clinical, and clinical testing to demonstrate that they are sufficiently “similar” in structure, function, efficacy, and safety to their reference innovator biologic.?
Building on our expertise in biologics, and our regulatory, commercial and manufacturing strengths, Pfizer is working to advance high-quality, safe and effective biosimilars that provide patients and prescribers with additional treatment options. With 30 years of experience manufacturing recombinant DNA products and significant expertise in the clinical development of novel products in many therapeutic areas, Pfizer is well positioned to meet the demand for manufacturing high quality biosimilars.
A biologic is a medicinal large molecule product that is synthesized from a living organism, which contains proteins from living cells. Precisely because biologics are much larger and more complex than typical small molecule drugs, the manufacturing processes for such products are highly complex. In the US, biologics are approved by the Food and Drug Administration (FDA) under a distinct process from new small molecule drug approvals.
Biologics have advanced patient care by providing highly effective, targeted treatment across multiple life-threatening and chronic diseases in therapeutic areas including: oncology, inflammation/immunology, rheumatology, gastroenterology, diabetes, neurology and inherited conditions.?
Standards for Biosimilarity
Because biosimilars are never exact copies of the innovator medicine, establishing appropriate standards for biosimilarity remains an important area for scientific, legislative and regulatory debate. Regulatory guidance for biosimilars has been developed in Europe, the United States and many countries throughout the world. Due to their complexity, biosimilars will be assessed based upon the “totality of evidence”. In this approach, extensive Chemistry Manufacturing and Controls (CM&C) evidence, together with limited nonclinical studies, detailed comparative human pharmacokinetics and comparative efficacy in a relevant patient population constitute the “totality of evidence” to help ensure patients receive high-quality and safe products.