AmerisourceBergen Expands Global Footprint and Commercialization Solutions with Acquisition of PharmaLex

The rapid rate of innovation across the biopharma industry can be captured in a statistic: nearly 75 percent of the products in clinical development could be first-in-class medicines.

The products being developed today – including potential first-in-class treatments and innovative therapies that target rare diseases – offer tremendous hope to patients worldwide, including those living with life-threatening or debilitating diseases. However, the pharmaceutical development and commercialization journey is lined with challenges and considerations that can impact commercial success and patient access. After back-to-back years of approving 50 or more novel drugs, the U.S. Food and Drug Administration (FDA) in 2022 approved 37 new products – the lowest total since 2016.

As pharma and biotech companies navigate new challenges, including growing regulatory complexities, global healthcare company AmerisourceBergen remains focused on elevating the support it can provide its partners to help them maximize product success and accelerate patient access, said Willis Chandler, president of Global Pharma Services at AmerisourceBergen.

Earlier this month AmerisourceBergen announced it completed the acquisition of PharmaLex, a global healthcare and life sciences consulting and outsourcing provider. PharmaLex, which is headquartered in Germany and has offices in more than 25 countries, is comprised of a team of scientific, regulatory and safety and compliance (GxP) experts that provide strategic guidance and regulatory support across the development and commercialization process. The company offers a portfolio of services, including technology-enabled solutions, that span the entire product lifecycle – from regulatory affairs and clinical development consulting to pharmacovigilance and quality management and compliance. 

PharmaLex’s end-to-end capabilities, said Chandler, complement AmerisourceBergen’s current portfolio of commercialization services and solutions, which includes market access, health economics and outcomes research (HEOR), field solutions and patient services. AmerisourceBergen – which in 2021 acquired Alliance Healthcare, a leading wholesaler of healthcare products in Europe – also offers global distribution and logistics services to support clinical and commercial products.

“By adding PharmaLex’s market-leading capabilities to our existing service offering, we’re able to provide pharmaceutical and biotech companies with enhanced support and value across the product lifecycle,” Chandler said. “Whether our partners require complete end-to-end support or a specific service, we are uniquely positioned to support their needs and help them achieve the outcomes they desire, including successfully launching products in the United States, Europe and Canada.”

Emerging Biopharma Companies Continue to Drive Growth

AmerisourceBergen’s acquisition of PharmaLex comes at a time when more small- to mid-sized biopharma companies are developing and launching their own drugs – going to market independently as opposed to selling their late-stage drugs or being acquired altogether by larger pharmaceutical companies.

And emerging biopharma companies account for a growing share of the products being developed today, with recent data suggesting the companies account for 65 percent of the molecules in the global R&D pipeline. For example, pre-commercial biopharma company Outlook Therapeutics is working to develop and launch an ophthalmic formulation of bevacizumab for use in retinal indications. Outlook Therapeutics in 2022 announced a strategic relationship with AmerisourceBergen in preparation for the anticipated commercial launch in the United States of ONS-5010. AmerisourceBergen will provide third-party logistics (3PL) services, distribution, medical information and pharmacovigilance services in the United States, pending FDA approval. As Outlook Therapeutics moves toward a potential launch in the United States, AmerisourceBergen’s commercialization support will expand to include additional services, such as patient services and field solutions. Outlook Therapeutics is also exploring a relationship with AmerisourceBergen to support the launch of ONS-5010 in international markets.

“One of the huge advantages for us as a small company is that having this kind of a relationship with AmerisourceBergen really puts us on an equal footing with the big companies in terms of being able to have access to the entire marketplace,” Outlook Therapeutics President and CEO Russ Trenary said in a recent interview.

Evolving Global Regulatory Landscape

Regulatory changes introduce new considerations for pharmaceutical and biotech companies planning to launch products. Reforms to the FDA’s accelerated approval process provides the agency with tighter controls on confirmatory trials, enabling the FDA to require studies are underway at the time of approval or after approval—within a specified period. The reforms also introduce expedited procedures for withdrawing accelerated approvals that fail to demonstrate post-approval efficacy. Meanwhile, biopharma companies looking to launch products in Europe need to understand – and plan for – the transition to pan-European Union (EU) joint clinical assessments, which will start for some new medicines in 2025 as part of new health technology assessment (HTA) regulation.

The dynamic and ever-changing environment underscores the need for regulatory consulting expertise and innovative solutions, said Thomas Dobmeyer, CEO of PharmaLex. PharmaLex has expanded its technology-enabled services portfolio to provide its partners with access to solutions that can help drive operational efficiencies and accelerate time-to-market. For example, PharmaLex offers several regulatory-focused, tech-elevated solutions, including automated regulatory information and submission management, regulatory intelligence and global end-to-end regulatory outsourcing solutions.

“In a complex international healthcare market, our global team of experts and innovative solutions enable us to deliver true business value across the product lifecycle—helping our clients bring specialty products to market or ensuring mature products continue to deliver against the highest standard,” Dobmeyer said. “Now that we are a part of AmerisourceBergen, our clients will have access to a more robust and expansive suite of global solutions and services—including distribution, 3PL and specialty logistics—that can be tailored to their specific needs. We will continue build on each other’s capabilities as we work alongside our clients to advance pharmaceutical innovation and access.”

To learn more about the support AmerisourceBergen can provide across the product lifecycle, check out: https://www.amerisourcebergen.com/manufacturer-solutions#therapeutic-areas