AbbVie’s recent US$ 100 billion voluntary three-year agreement with the US government to lower drug prices on select medicines marks a significant shift in drug pricing negotiations, directly linking tariff exemptions and pricing flexibility to expanded domestic manufacturing.
Alongside new US Food and Drug Administration (FDA) reforms, the deal demonstrates a policy-driven transformation that places capital investment, supply chain resilience, and advanced biologics capabilities at the forefront of US pharmaceutical strategy. This conclusion is based on a recently published report by GlobalData.
“This agreement highlights a fundamental reorientation of US drug pricing policy, with domestic manufacturing investment now a central factor in negotiations,” noted Edita Hamzic, a Healthcare Analyst at GlobalData.
“By securing exemptions from import tariffs and future price controls, AbbVie gains the freedom to scale up manufacturing, modernize technologies, and reinforce supply chain security while investing in its development pipeline,” Hamzic added.
“AbbVie’s mission is to make a remarkable impact for the patients we serve around the world through our innovative medicines,” explained Robert A. Michael, chairman and chief executive officer of AbbVie.
“With approximately 29,000 U.S.-based employees and products treating 16 million Americans annually, we understand the complexity and access challenges in our healthcare system,” Michael said, who further noted that the agreement addresses the government’s drug pricing priorities and provides exemptions from tariffs and future price mandates, while reflecting the full value of U.S. medical innovation.
Flexibility to Advance Innovation
The FDA is introducing new flexibilities for cell and gene therapy (CGT) manufacturing, easing certain chemistry, manufacturing, and control (CMC) requirements to better align with the unique, small-batch nature of these treatments.
CGTs are inherently complex biologic products, often individualized for patients, and may need sophisticated manufacturing under particular time constraints. CBER has leveraged its growing experience with CGT products to identify and implement regulatory flexibilities allowed under the FDA’s regulations that accommodate the unique characteristics of these innovative therapies, while maintaining rigorous quality standards through appropriate control measures.
While there is a long history of making concerted efforts to help sponsors meet standards to assure product safety, purity, and potency, the application of flexibilities has not always been fully clear to stakeholders. This may change as a result of the introduced regulatory flexibility.
“These are common-sense reforms that will address the unique characteristics of cell and gene therapies and foster more innovation,” explained Marty Makary, M.D., M.P.H., the FDA Commissioner.
Over the last decade, the FDA’s Center for Biologics Evaluation and Research (CBER) has approved close to 50 CGTs. The transformative potential of these therapies has captured the imagination of the patient community and ignited product development.
“There has been tremendous enthusiasm amongst product developers resulting in an explosive growth of cell and gene therapy submissions, many of which target serious or life-threatening conditions with an unmet medical need,” Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research.
“CBER is eager for stakeholders to know that our effectiveness at exercising greater regulatory flexibility around chemistry, manufacturing, and control requirements furthers innovative product development,” Prasad noted.
CBER will now allow greater discretion for minor manufacturing changes during development and, in specific cases, eliminate the need for three separate Process Performance Qualification runs before commercialization, aiming to reduce bottlenecks while upholding safety and quality standards.
“CBER is proactively communicating about regulatory flexibilities that were previously applied case-by-case to select CGT therapies,”
“By communicating these approaches broadly, we aim to expedite product development across the CGT field,” said Vijay Kumar M.D., Acting Director, Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research.
“It is vital that every sponsor, no matter the CBER reviewer team they engage with, understand what types of regulatory flexibility may be scientifically acceptable.”
According to the FDA, the increased flexibility is primarily intended to remove barriers and address perceived misconceptions that impede expedited product development. The expectation is that these flexibilities will enable progress without compromising or undermining the FDA’s ability to assure the safety, purity, and potency of a product, or weakening the agency’s understanding of the benefits and risks of both the specific therapy and the disease context.
Reshaping Global Manufacturing
Industry investment is also reshaping global biologics manufacturing. Zydus Lifesciences has acquired Agenus’s biologics facilities in Emeryville and Berkeley, California, for US $75 million. The facilities operated by Zydus subsidiary Zylodac Bio specialize in end-to-end commercial-grade manufacturing, including antibody production and fill-finish services. The acquisition is part of Zydus’ strategy to launch a US-based BioCDMO subsidiary and secure exclusive manufacturing of the clinical and commercial supply of Agenus’s Phase 3 immuno-oncology candidates, botensilimab and balstilimab (BOT+BAL) combination.
“Closing this collaboration with Zydus strengthens our balance sheet and, critically, secures dedicated U.S. manufacturing capacity at a pivotal moment for Agenus,” noted Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus.
“With these foundations in place, our focus in 2026 is disciplined execution—advancing our Phase 3 program, broadening paid patient access through authorized pathways, and progressing toward regulatory submission supported by one of the most substantial clinical datasets generated in MSS colorectal cancer,” Armen added.
“With this deal, Zylidac Bio will now provide biological manufacturing sites offering CDMO services to biopharmaceutical companies globally,” added Sharvil P. Patel, Ph.D., Managing Director of Zydus Lifesciences.
“This supports the evolving landscape of biological product manufacturing in the U.S., which prioritizes secure, domestic, and high-quality supply chains for advanced therapies. [We now] offer a critical, compliant solution for global innovators and allow for a localized supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation,” Patel concluded.
Meeting Regional Production Needs
Meanwhile, Cellares has signed a long-term lease for an automated cell therapy manufacturing facility at Leiden Bio Science Park in the Netherlands, with operations set to begin in early 2026—reinforcing Europe’s expanding role in advanced cell therapy production.
Cell and gene therapy (CGT) manufacturing is patient-specific and time-sensitive. This makes regional production capacity increasingly important as programs advance from clinical development toward commercial supply. Cellares’ choice to expand commercial-scale manufacturing capacity for European cell and gene therapy patient populations through a standardized, automated, and highly scalable facility model,”… gives [us] a local supply path while keeping control consistent across geographies through a single automated standard,” said Fabian Gerlinghaus, Co-founder and CEO of Cellares.
The European site in Leiden is, according to Gerlinghaus, “Intended to support automated cell therapy manufacturing programs for European and global partners as they plan regional clinical and commercial supply. Following delivery and completion of the fit-out, the Netherlands Smart Factory is expected to deploy Cellares’ fully automated Cell Shuttle™ manufacturing platforms and Cell Q™ quality control systems to enable consistent execution and streamlined process transfer across geographies, extending the company’s global IDMO network across North America, Asia, and Europe.
“As tariff relief, policy incentives, and FDA flexibilities intersect, companies that localize advanced biologics and cell therapy manufacturing will gain both regulatory and pricing advantages. Policy alignment is set to become as influential as market demand in shaping future capital investments,” Hamzic concluded.
Strengthening ADC Pipeline
As part of its strategy, Pfizer considers enfortumab vedotin (Padcev®; Astellas Pharma and Pfizer), a first-in-class antibody-drug conjugate (ADC) targeting Nectin-4, co-developed and commercialized by Astellas Pharma and Seagen (now part of Pfizer), the potential growth driver for its oncology segment and pipeline, and plans the heavely invest in the further development, commercialization, and partnerships.
Based on the outcomes from the Phase 3 KEYNOTE-905 clinical study (NCT03924895) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy, Pfizer believes that the combination of pembrolizumab (Keytruda®; Merck & Co/MSD) plus enfortumab vedotin, given before and after radical cystectomy, significantly transforms the treatment landscape for both metastatic and early-stage muscle-invasive bladder cancer.
The study outcomes demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, as well as overall survival (OS) and pathologic complete response (pCR) rate, key secondary endpoints, compared to radical cystectomy alone. [1] The combination of pembrolizumab plus enfortumab vedotin represents a potential new standard of care, expanding eligibility for patients.
ASCO GU
Data across multiple genitourinary cancers from several approved and investigational medicines will be presented at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place at Moscone West in San Francisco, CA, from February 26-28, 2026.
First-time, late-breaking data from the KEYNOTE-B15 study (NCT04700124) demonstrate that pembrolizumab plus enfortumab vedotin as neoadjuvant and adjuvant treatment for patients with muscle-invasive bladder cancer who are eligible for cisplatin significantly improved event-free survival, overall survival, and pathologic complete response rates for patients with certain types of bladder cancer (abstract #LBA630, Oral abstract session B: Urothelial carcinoma).[2]
“We’re excited to share new results from our portfolio and pipeline for more patients with certain types of bladder and kidney cancers, with new data in muscle invasive bladder cancer and earlier stages of renal cell carcinoma,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
“The results we’re presenting at ASCO GU underscore our leadership across the genitourinary cancer landscape and our commitment to advance standards of care for these patients,” she concluded.
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Clinical trials
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) – ClinicalTrials.gov ID NCT03924895
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) (KEYNOTE-B15) – ClinicalTrials.gov ID NCT04700124
Highlights of prescribing information
Brentuximab vedotin(Adcetris®; Pfizer)[Prescribing Information]
Enfortumab vedotin (Padcev®; Astellas Pharma and Pfizer)[Prescribing Information]
Pembrolizumab (Keytruda®; Merck & Co/MSD)[Prescribing Information]
Reference
[1] Vulsteke C, Adra N, Danchaivijitr P, Sabadash M, Rodriguez-Vida A, Zhang Z, Atduev V, Göger YE, Rausch S, Kang SH, Loriot Y, Bedke J, Galsky MD, O’Donnell PH, von Amsberg G, Alimohamed N, Sulimka G, Gupta S, Paramonov V, Nakane K, Mihm M, Meng C, Huang CD, Ramamurthy C, Homet Moreno B, Ullén A; KEYNOTE-905/EV-303 Investigators. Perioperative Enfortumab Vedotin and Pembrolizumab in Bladder Cancer. N Engl J Med. 2026 Feb 18. doi: 10.1056/NEJMoa2511674. Epub ahead of print. PMID: 41707170.
[2] Galsky MD, Valderrama BP, Maruzzo M, Pous AF, Ciuleanu TE, Chatzkel JA, Koie T, Hoimes CJ, Puente J, Zakharia Y, Rosenbaum E, Boehm K, Loriot Y, Bedke J, Wirtz H, Mihm M, Huang Q, Rogiers J, Homet Moreno B, Gomez De Liaño Lista A. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. J Clin Oncol 44, 2026 (suppl 7; abstr LBA630) Doi 10.1200/JCO.2026.44.7_suppl.LBA630
Featured image courtesy © 2025 – 2026 Pfizer. Used with permission
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