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Biosimilars Law Blog

Our Services

With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, including many with experience at the FDA and other key agencies, in the industry, and others holding advanced degrees in relevant disciplines, Hogan Lovells offer timely, effective counsel on a wide variety of matters. These include:

  • Approval pathways and standards
  • Biosimilars/follow-on biologics
  • Cellular and tissue-based products
  • cGMP Compliance
  • Clinical trials
  • Combination products
  • Controlled Substances
  • Corporate transactions and commercial agreements
  • Coverage, reimbursement, and pricing
  • Exclusivities (marketing/data)
  • FDA enforcement
  • Hatch-Waxman
  • Intellectual Property
  • Internal investigations
  • Labeling, advertising, and promotion
  • Life cycle management
  • Litigation
  • Over-the-counter drugs
  • REMS/drug safety
  • State reporting and licensing

Whether your products are traditional drugs or biotechnology products, we work with you to successfully develop and commercialize products, addressing issues of regulatory approvals and compliance; coverage, reimbursement, and pricing; and careful use of intellectual property and regulatory exclusivities to manage product life cycles.

Our multidisciplinary team leverages the skills and experience of colleagues in other disciplines—including healthcare compliance (such as coverage, reimbursement, pricing, and fraud and abuse prevention), public policy, intellectual property, corporate and securities law, and litigation—to provide integrated, strategic, and practical advice for successful product development and marketing and effective responses to regulators and competitors.

We use our global network of 2,500 lawyers in more than 40 offices to support your multinational and cross-border strategies, opening your innovations to a global presence that maximizes their potential.