FDA approval of biosimilars
FDA Approval of Biosimilars: Overview
What are Biosimilars?
Biosimilars are biological products highly similar to an already FDA-approved biologic, known as the reference product, with no clinically meaningful differences in safety, purity, or potency.
Unlike generic drugs, biosimilars are not exact copies due to the complex nature of biologics.
Biosimilars offer potentially lower-cost alternatives to expensive biologic therapies.
Regulatory Framework
The Biologics Price Competition and Innovation Act (BPCIA) of 2009 created an abbreviated pathway for FDA approval of biosimilars.
Biosimilar manufacturers file a 351(k) application demonstrating biosimilarity to the reference product.
The FDA evaluates analytical, animal, and clinical data to ensure no meaningful differences.
The BPCIA also establishes a process for resolving patent disputes between biosimilar and reference product sponsors.
Key Legal Issues in FDA Biosimilar Approval
Patent litigation and the “patent dance”: Statutory procedures for exchanging information and resolving patent disputes.
FDA’s discretion in approval: Challenges over the scope of data required.
Interchangeability designation: Additional FDA approval step allowing pharmacy-level substitution.
Important Case Law on FDA Biosimilar Approval
1. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015)
Facts: Sandoz submitted a biosimilar application and notified Amgen of its intent to market, triggering the patent dispute process under the BPCIA.
Issue: Whether the BPCIA requires the biosimilar applicant to provide its application and manufacturing information to the reference sponsor (the “patent dance”).
Holding: The Federal Circuit held the “patent dance” is a statutory requirement but remedies exist if a party fails to comply.
Significance: Clarified the patent dispute process and consequences for non-compliance.
2. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017)
Facts: After Amgen sued over patent disputes, Sandoz sought to market its biosimilar before the 180-day notice period.
Issue: Whether the 180-day notice of commercial marketing can be given before FDA approval.
Holding: The Supreme Court ruled the notice can only be given after FDA approval, not before.
Significance: Established timing rules affecting market entry and patent litigation strategy.
3. Genentech, Inc. v. Amgen Inc., 2018 WL 3656587 (N.D. Cal. 2018)
Facts: Dispute over whether biosimilar manufacturer must provide full access to manufacturing information.
Issue: Scope of the “patent dance” disclosures.
Holding: Courts generally enforce the “patent dance” information exchange but allow remedies for partial compliance.
Significance: Reinforces cooperation between biosimilar and reference sponsors during patent disputes.
4. Celltrion Healthcare Co. v. FDA, 566 F. Supp. 3d 27 (D.D.C. 2021)
Facts: Challenge to FDA’s approval of a competing biosimilar, alleging inadequate review.
Issue: Whether FDA’s approval decision was arbitrary or capricious.
Holding: Court deferred to FDA’s scientific expertise and upheld the approval.
Significance: Courts generally give deference to FDA decisions on scientific and clinical data.
5. Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., 2020 WL 6686306 (D. Mass. 2020)
Facts: Patent infringement litigation involving biosimilar products.
Issue: Interpretation of BPCIA provisions regarding patent enforcement.
Holding: Courts closely interpret statutory provisions to balance innovation incentives and competition.
Significance: Highlights the complex patent landscape in biosimilar approvals.
Summary Table of Case Law
| Case | Holding | Legal Principle |
|---|---|---|
| Amgen v. Sandoz (2015) | “Patent dance” disclosure is statutorily required | Patent litigation procedures under BPCIA |
| Sandoz v. Amgen (2017) | 180-day notice of marketing only after FDA approval | Timing of market entry and patent notice |
| Genentech v. Amgen (2018) | Enforcement of patent dance with remedies for noncompliance | Cooperation and disclosure obligations |
| Celltrion v. FDA (2021) | FDA approval decisions get judicial deference | Deference to agency scientific judgments |
| Momenta v. BMS (2020) | Careful statutory interpretation of BPCIA | Balance between patent protection and biosimilar competition |
Conclusion
The FDA approval of biosimilars is governed by a carefully constructed statutory framework balancing innovation incentives and competition. Courts have played a critical role in interpreting the BPCIA’s patent dispute procedures and timing, while generally deferring to FDA’s scientific judgment on biosimilarity. This evolving jurisprudence shapes how biosimilars enter the market and impacts patient access and drug pricing.
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