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By Carol Kirchhoff and Shefali Kakar

Carol Kirchhoff-finalKakar Shefali-finalA biosimilar is the term used to describe a biological therapeutic that has been developed to be highly similar to a marketed innovator biological therapeutic (reference product) that has exhausted patent protection. However, because the innovator product and the biosimilar are both produced by protein expression in living organisms followed by purification, it is recognized that even well controlled protein production processes may be variable and that different cell lines and fermentation conditions may result in similar, but not identical protein generation. Both established biotechnology/pharma companies and start-ups are attempting to develop and launch biosimilar products into the marketplace to provide patients, physicians, and payers with additional alternatives for patient care at lower cost.

Biosimilars are relatively new to the pharmaceutical landscape. Regulatory pathways toward approval of biosimilars are still under development in many parts of the globe. In some countries, pathways have been fully developed. In others, pathways have been developed, but not tested. For example, biosimilars have been successfully approved and marketed in Europe since 2006 with ten approved biosimilar products, while none have yet been approved in the United States, although the regulatory pathway was established in 2010.

Unlike with traditional small molecule generics, biosimilar development requires significant data beyond a pharmacokinetic equivalence study. There is a strong emphasis on analytical characterization and similarity assessments between the biosimilar to the innovator (reference) product. Furthermore, non-clinical and clinical comparisons are much more extensive than required for small molecule. The final focus of the license application submission is the totality of evidence supporting biosimilarity. A series of recent submissions and approvals are forging a new path for biosimilar approvals using this totality of evidence approach.

Biologics are indispensable in alleviating morbidity and mortality in many illnesses and biosimilar programs are encouraged by the Affordable Care Act. Biosimilars have the potential to generate savings and efficiencies for healthcare systems, which can help free up resources for other important aspects of healthcare. The tailored approach to biosimilar development involves complex manufacturing, extensive product characterization and bioanalytical scrutiny, and a significant investment in conducting clinical trials

The AAPS Biosimilars Focus Group (BSFG) was established under the BIOTEC Section in March 2014. The mission of the BSFG is to provide a forum to discuss biosimilars as a broad topic, enabling feedback and perspectives from all areas involved in biosimilar development. The BSFG has seven subcommittees: Regulatory, Clinical/ Immunology, Clinical PK/PD, Non-clinical/Clinical Assay, Non-clinical (in vivo), Intellectual Property, CMC-Analytical, and CMC-DS/DP. The BSFG continues to invite AAPS members with expertise to volunteer.

Two programs at the 2014 AAPS Annual Meeting and Exposition will provide attendees with the opportunity to learn more about biosimilars:

At the hot topic session Biosimilar Clinical Pharmacology Guidance (Shefali Kakar, moderator) Darrell Abernethy (United States Food and Drug Administration [FDA]), and Sally Choe (PAREXEL Consulting) will share their perspectives on the newly proposed draft guidance from FDA.

At the symposium Recent Biosimilar Approvals (Carol Kirchhoff, moderator) several speakers will introduce and share their experiences with biosimilars. Shefali Kakar (Novartis), Suzanne Sensabaugh (Hartmann Willner, LLC), Carlos Sattler (Sandoz), and Alex Kudrin (Celltrion) will provide case studies of approved biosimilars, highlighting the successes and challenges associated with the biosimilars development and approval processes in multiple countries. Some examples include the first monoclonal antibody biosimilar approval in Europe, Celltrion’s Remsima, and the first biosimilar submission in the United States: Sandoz’s Filgrastim.

Join us on November 4 for the hot topic discussion on FDA’s most recent biosimilars draft guidance and on November 6 for an overview of currently approved biosimilars and evolving regulatory pathways for future global development of biosimilars. We look forward to seeing you in San Diego!

Carol Kirchhoff is a director in the BioManufacturing Sciences Group at Pfizer and a CMC team leader for multiple products in Pfizer’s biosimilar portfolio. She is the chair of the AAPS Biosimilars Focus Group.
Shefali Kakar is a senior director in the Novartis Oncology Clinical Pharmacology group. She leads the clinical pharmacology group for Oncology biosimilars within the Sandoz/Novartis Biosimilar portfolio. She is the chair elect of the AAPS Biosimilars Focus group.