Top 5 Most-Read Legal Articles of 2024

The top legal developments in biosimilars for 2024 reveal a complex interplay between innovation, access, and regulation. Cases of litigation, policy milestones, and systemic challenges highlight the tension between fostering competition and navigating entrenched legal frameworks. From landmark lawsuits to evolving patent strategies, these narratives underscore the delicate balance required to advance affordable biologics while preserving incentives for innovation.

Here are the top 5 legal biosimilar articles in 2024.

The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges that shape the competitive landscape of affordable biologics. | Image credit: inthasone - stock.adobe.com

5. Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

Regeneron is appealing a federal judge's decision that allows Amgen to proceed with the launch of its Eylea (aflibercept) biosimilar, Pavblu (aflibercept-ayyh), after the court rejected Regeneron’s request for a preliminary injunction. Prime Therapeutics announced plans to include low-cost adalimumab biosimilars in its pharmacy benefit plans starting in 2025, offering flexible strategies to increase accessibility. Meanwhile, the FDA and European Medicines Agency accepted Alvotech and Teva Pharmaceuticals’ denosumab biosimilar candidate for regulatory review, potentially expanding access to osteoporosis and cancer-related bone treatment options.

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4. Patient With MS Sues J&J Over ERISA Violation

Ann Lewandowski, a Johnson & Johnson (J&J) employee with multiple sclerosis (MS), filed a class action lawsuit accusing J&J and its Pension & Benefits Committee of violating the Employee Retirement Income Security Act (ERISA) by mismanaging prescription drug benefits. The lawsuit claims that J&J's pharmacy benefit manager (PBM) directed beneficiaries toward higher-cost branded drugs, such as teriflunomide (Aubagio), over cheaper generic alternatives, leading to inflated costs for employees. The case seeks to hold J&J accountable for failing to act in the best interests of its employees and could set a precedent for improved oversight of employee benefit plans under ERISA.

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3. Patent Dance Insights: A Q&A on Reducing Legal Battles in the Biosimilar Landscape

Ha Kung Wong, JD, explains the patent system for biosimilars under the Biologics Price Competition and Innovation Act, emphasizing its 2-phased litigation process. The "patent dance," an optional information exchange between biosimilar developers and reference product sponsors, allows disputes to be resolved early, minimizing unnecessary litigation. While effective in streamlining approvals and encouraging settlements, Wong noted potential legislative changes, including patent reform and PBM scrutiny, which could impact biosimilar adoption and market dynamics.

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2. The Hatch-Waxman Act Turns 40: The Law That Made Biosimilars Possible

The Hatch-Waxman Act, marking its 40th anniversary, has been pivotal in promoting the development of generic drugs, fostering competition, and driving cost savings for patients. However, a white paper by the Association for Accessible Medicines highlighted challenges like price deflation, slower adoption of biosimilars, and market fragility, compounded by market consolidation and patent disputes. It recommended policy reforms to enhance generic and biosimilar market sustainability, address pricing uncertainties, and ensure timely patient access to affordable medicines.

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1. What Types of Patents Are to Blame for Biosimilar Market Delays?

A study revealed that manufacturing patents are not the primary cause of biosimilar market launch delays, contrary to common belief. Instead, delays are influenced by extensive patent litigation, particularly related to active pharmaceutical ingredients, treatment methods, and composition of matter, with settlements often resulting in prolonged market entry. The findings highlight the complex interplay between patent portfolios, litigation outcomes, and regulatory frameworks, raising questions about the balance between innovation incentives and timely access to affordable biologics.

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