Strategic Launch Sequencing
Biopharma new product strategic launch sequencing (SLS) is becoming increasingly more controversial and complex. In this article on biopharma new product SLS, we will the review the background and new challenges that the Biopharma industry faces in new product launch sequencing. We will also discuss potential ramifications associated with delays in Biopharma drug launches and how modern Biopharma new product SLS needs to evolve and some of the new factors that it must now consider.
SLS has been a cornerstone of Biopharma new product launch strategies for decades. In response to higher evidentiary standards for access and pricing as well as ex-U.S. reference pricing, parallel trade, and willingness to pay (WTP) practices, Biopharma companies for decades have carefully strategized and planned the sequencing of new product launches across the globe. For innovative new products with well-constructed clinical trial designs, evidence generation plans, and proven magnitude of effect (MOE), traditional SLS has focused on initial launches in large markets with a high WTP such as Germany, Japan, France, Switzerland and Italy so as to establish a high ceiling price for subsequent countries that referenced to these markets. The strategy typically delays subsequent launches in smaller markets with a lower WTP and especially in those markets that commonly leak confidential net pricing. In cases where a product lacked sufficient clinical trial design or MOE, manufacturers would sometimes delay launches in Germany and France and look to establish a higher price ceiling by first launching in smaller EU countries with less rigorous evidence requirements. While multifactorial, this traditional launch strategy has contributed to the delays seen in access to innovative drugs across the EU. A recent report by EFPIA has shown that European patients face an average 578-day delay between EMA approval to actual access to innovative new medicines, with significant inequity between countries and substantially longer delays for oncology and orphan drugs.
However, traditional launch sequencing has become increasingly more complex. U.S. policies such as the IRA and MFN have placed a greater emphasis on pipeline prioritization of various indications for the same new drug product and specified country launch sequencing. In addition, pricing reforms in the EU and Japan have dramatically raised evidentiary standards for access and optimal pricing, led to dramatic changes in individual countries WTP, as well as significant shifts in reference pricing market baskets and calculations. For example, recent Japanese drug pricing reforms have dramatically reduced the market basket size that is employed to just four countries (DE, FR, US, UK), shifted from a weighted average calculation to the lowest price seen in the across the market basket, and shifted from pre-AMONG (free pricing) to post-AMONG net negotiated pricing in Germany.
This complexity has led many Biopharma companies to begin to dramatically delay ex-U.S. new product launches. According to a March 31, 2026 Reuters article, pharmaceutical companies have delayed new drug launches in Europe by roughly 35% in the 10 months since Trump's MFN executive order to avoid lower European prices from negatively impacting U.S. pricing. The article also suggests that the recent withdrawal of drugs from Denmark and Sweden by Amgen and Indivior may be in response to U.S. MFN policies. Reuters noted that “companies such as Insmed delayed the German launch of its anti-inflammatory drug Brunspri, and other firms are re-evaluating European, UK-EU, and even early-access pathways in countries like France.” The CEO of Insmed went on to say that “we want clarity on the MFN policies…. It seems to us that the prudent thing to do is to sort of put things on hold until we know what that's going to look like." Insmed gained EMA approved in November 2025 but has yet to launch in the EU. Biopharma executives from Roche, Novartis and AstraZeneca, as well as EFPIA, pointed to data showing that the EU spends far less of its GDP on pharmaceuticals than the U.S. and even China, and AstraZeneca’s CEO Pacal Soriot referred to such delays or cancellation of EU launches as a “mathematical necessity.”
However, a strategy of simply delaying ex-U.S. launches has the potential to backfire on the industry. Not only does it reduce launch revenues, but it could potentially reduce the patent life for new drug products in the EU, push ex-U.S. Governments to adopt even stricter price concessions, and cause western Biopharma companies to forfeit future revenues to Chinese manufacturers. In late 2025, the new EUC Pharma Package reached a provisional agreement that could drastically modify long standing EU drug patent rules whereby manufacturers could lose 12 months of market protections if manufacturers do not launch EMA approved medicines across all EU countries within a 3-year timeframe. While this new agreement is not to be implemented until 2028, it is already actively influencing regulatory and commercial strategies, and could easily be tighten further should the Biopharma trend towards delaying EU launches continue. In response to higher drug costs, and in the face of Trump’s MFN policy, the German Government has proposed to adopt a new law (GKV-BStabG) that would extent German price caps on pharmaceutical through 2030 and increase the existing mandatory markdowns on list price. Further complicating EU SLS, the EU Joint Clinical Assessment (JCA) is now mandatory for all new oncology drugs and Advanced Therapy Medicinal Products and will expand to orphan drugs in 2028. The JCA review runs in parallel with the EMA approval process and is designed to assess the scientific validity of new drug study data and to evaluate the relative clinical effectiveness and safety of new medicines. National HTA bodies are not legally bound by the JCA’s evaluations and retain full responsibility for their country’s final product benefit ratings, economic and cost effectiveness assessments, pricing, and reimbursement decisions remain strictly the responsibility of national health authorities in each country.
Meanwhile China recently assumed the international lead in biopharma R&D. Between 2025 and 2026, ~30% of global R&D was originated in China, with 46% of new in-human trials occurring in China. China now leads the US with over 7,100 clinical trials with a large focus on innovative new oncology targets and treatments. As western Biopharma companies continue to delay ex-U.S. product launches, China is well posed to fill the gap in EU availability of novel new medicines and thereby take substantial ex-U.S. revenues from western Biopharma companies
Hence, today’s Global Biopharma launch sequencing strategy needs to evolve and must begin to consider a multitude of new factors including:
How they will comply with the newly introduced MFN CMS/CMMI MFN Demonstration projects.
The need to achieve visible GDP adjusted pricing outside of the U.S. that equals or exceeds the CMS defined Medicare Net price.
The limited period between U.S. FDA approval and IRA mandated Medicare price negotiations and its impact on pipeline prioritization and launch sequencing.
The lag between FDA and EMA approvals, and the potential adoption of differences in the approved EMA and FDA indications.
The EU mandate for JCA and the ever-increasing Ex-U.S. evidentiary standards for access and optimal pricing which both have a significant impact on clinical trial design and Integrated Evidence Generation Planning.
Rapidly changing ex-U.S. parallel trade and referencing pricing practices.
Ex-U.S. acceptance of revised and more rigorous biopharma contracting terms, innovative contracting practices, and modified discounting structures.
The continued response from the EU and other ex-U.S. countries to increasing delays in ex-U.S. product launches and innovative product availability, including the evolution and implementation of the revised patent protections within the EUC Pharma Package.
Ever changing Tariff policies
For a better understanding of how to integrate these various factors into a comprehensive modern day launch sequencing strategy, please do not hesitate to contact either me or Rita Numerof.