Biosimilars
What are biosimilars?
Biosimilars or follow-on biologics are officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following the expiration of patent exclusivity on the original product.
The term “biosimilar” comes from the European Medicines Agency’s (EMEA) recognition that no two cell lines that are developed independently can ever be considered identical. Because of the fact that 1) small differences in the cell line or 2) the manufacturing process can make a difference in how the biologic performs and in the immunogenic response it triggers in humans (as compared to the original product), the approval pathway is complex, as are pharmacovigilance approaches and a number of other issues related to biosimilars.
In the following biosimilars section, our members will further investigate and discuss current regulations, scientific and legal developments, and initiatives on the horizon relating to biosimilars. We welcome your questions and discussion.
Our biosimilars team:
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Robyn S. Shapiro is a partner in the Health Care Practice Group. She has significant experience in representing clients with respect to bioethics issues, medical staff matters, health information privacy, informed consent, regulatory and licensing matters, human subjects research compliance and employment and other business issues.
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Christine Norris is an associate in the Intellectual Property Practice Group. Her technical experience includes genomics, proteomics, biotechnology, neuroscience, molecular and cell biology.
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Leslie M. Tector is counsel in the firm’s Health Law Practice Group. Her practice focuses on research compliance, regulatory health care and general corporate matters. Leslie provides clients with guidance on research compliance, regulatory health care and general corporate matters.
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Debora Plehn-Dujowich, Ph.D. is an associate in the Intellectual Property Practice Group on the Patents Team. She focuses her practice on biotechnology and biochemistry.
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Anna Schwamlein Howard is the Medicare Reimbursement & Health Policy Director on the firm’s Lobbying & Advocacy team. A nationally recognized authority on health care reform issues, Anna has considerable experience in government relations and regulatory affairs
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