Biosimilars

End-to-End Expertise for Biosimilar Success

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The development of biosimilars is filled with unique challenges, including navigating diverse regulatory pathways, managing complex clinical trials, and addressing pricing and market access barriers in the US, EU, and global markets.

Our team is your trusted partner in overcoming these hurdles. We provide tailored support for every step—from selecting the right CDMO and designing GMP-compliant facilities to optimizing market access strategies and ensuring the successful commercialization of your biosimilar product.

Full Lifecycle of Services for Your Success in Biosimilar Projects

CMC

Regulatory and Clinical Pharmacology

Clinical and Biometrics

Market Access

Commercial

Transaction Advisory

CMC

Regulatory and Clinical Pharmacology

Clinical and Biometrics

Market Access

Commercial

Transaction Advisory

Why Partner With Us?

A comprehensive understanding of the unique challenges for biosimilars in supply chain management and manufacturing, navigating the IP landscape, regulatory pathways, and in achieving market share in these competitive markets.
Broad network across the biosimilar ecosystem, including R&D houses, biotech and generics players, and biologic CDMOs.
Intricate understanding of the US contracting environment, ranging from hospitals and 340(b), group practices, payers and GPOs.
An extensive track record of over 15 projects in the biosimilar space in the past five years, including a successful capital market transaction and multiple out-licensing deals.

The biosimilar market is ripe with opportunity, but success demands a holistic strategy that unites manufacturing, regulatory, clinical, and commercial elements from the outset. At Alira Health, we help developers navigate these complexities, building robust business cases that maximize market potential and ensure long-term sustainability. With our deep industry expertise and tailored approach, we empower clients to confidently bring their biosimilar products to market.

Joris Pezzini
Executive Vice President, Biopharma

Latest Biosimilar Publications

2024 Global Biosimilars Report

Recent biosimilar product launches have achieved nearly 70% market share by volume within two years of launch. Download our assessment of trends in the global biosimilar market, with an emphasis on market and competitive dynamics in the US and Europe.

Download

Navigating Growth: Insights into the Expanding Global Biosimilars Market 2024

To learn more about the drivers and restraints in biosimilars, as well as predictions for the next decade, we spoke with Christian Hughes, Senior Manager, Transaction Advisory Services.

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Family Office Optimizes Biosimilar Investments Through Strategic Capital Market Transaction

A client reached out to appropriately value two biosimilar assets, facilitate discussions with its management, and coordinate the capital market transaction as an asset-contribution in kind.