Biologics

RMMS is the only specialty litigation and counseling boutique in the United States devoted almost exclusively to the pharmaceutical industry, and our collective experience is second to none.

RMMS attorneys have litigated patents related to life sciences and pharmaceuticals for over 20 years, and thus, are well prepared to adjust to the changing biosimilars industry.  Our team is well-versed in all aspects of the Biologics Price Competition and Innovation Act (BPCIA), and regularly guides clients through the complex provisions of the BPCIA as well as resulting litigation.

In addition, RMMS regularly counsels clients on regulatory issues related to the Hatch-Waxman Act and the BPCIA, including expedited FDA review strategies for drugs and biological products, patent listing and certification issues, product labeling, agency review requirements, risk management programs, marketing exclusivities, and citizen petitions.

RMMS continues to expand its biosimilar practice, including consulting and strategy development in advance of application filing, as well as our involvement in cutting-edge, first-of-of their kind court decisions related to biosimilar products.

Biologics HighlightsView All

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