EU Biotech Act Ignites a New Wave of Biologics Partnerships

• The European Commission’s newly unveiled EU Biotech Act is set to transform the continent’s biopharma landscape in 2026.
• Health biotechnology represents roughly 75% of the biotech sector’s value, making it a key driver of medical innovation.
• By reducing bureaucratic hurdles and bolstering support for emerging therapies, the Biotech Act signals a commitment to ensure Europe remains a competitive, world-leading hub for developing new biologic medicines.

Forging Biotech Partnerships in the 2026 EU Biotech Act Era 

Biotechnology is one of the fastest growing sectors in the EU. It currently provides over 900,000 jobs and contributes nearly €40 billion to the European economy. The proposed EU Biotech Act will increase Europe’s biotechnology potential by supporting the process of bringing innovative ideas from the laboratory to the market. The European Commission’s actions are a response to the growing gap between Europe’s strong scientific base and its weaker industrial and financial performance in the biotech sector. The EU attracts only about 7% of global venture capital investment in medical biotechnology, while its share of global commercial clinical trials has fallen from 22% to 12% over the last decade. The Biotech Act aims to address these challenges by reducing regulatory complexity, accelerating development timelines, and improving access to investment capital for biotechnology companies operating in Europe.

Key measures in the EU Biotech Act are designed to speed breakthroughs from lab to clinic. The Act includes measures to:

• Provide targeted support for high-impact projects to boost biomanufacturing capacity
• Streamline multi-country clinical trial approvals and fast-track development of cutting-edge therapies
• Simplify EU regulatory procedures to reduce costs for companies
• Establish a new EU investment facility, making it easier for biotech companies to access growth funding

Together, these changes aim to accelerate innovation, reduce regulatory hurdles, and improve conditions for growth and scale-upof biotech ventures in Europe. One immediate benefit is the plan to make the EU’s Clinical Trials Regulation more workable so that pan-European trials can launch faster and with less red tape.¹

Another pillar is improved financing. The Act introduces a venture funding instrument via the European Investment Bank, mobilizing around €1 billion to help scale up promising biotech companies that are not yet ready for public markets. By incentivizing companies to conduct R&D and production in Europe, offering easier access to capital, and fast-tracking approvals, the EU Biotech Act creates a fertile environment for developing new biologic therapies.²

Biotech innovators can leverage these reforms to advance monoclonal antibodies, recombinant proteins, vaccines and other biologics more efficiently – ultimately bringing novel treatments to patients sooner. Industry leaders have welcomed the Act as a pivotal moment that will help Europe compete globally in biotechnology, provided its measures are implemented swiftly.³

Mabion’s Co-Development Model: Partnering for Breakthrough Biologics 

Amid this vibrant European biotech upswing, Mabion is intensifying cooperation with biotech companies in 2026 through a partnership-driven approach. Rather than relying solely on traditional fee-for-service contracts, Mabion is embracing co-development models that share in the risks, costs, and potential rewards of ambitious biologic drug projects. This collaborative model is especially attractive for programs involving cutting-edge modalities (like antibody–drug conjugates drug candidates or next-generation nanobodies) which carry higher technological or regulatory uncertainty.

In today’s market, clients seek true partners, not just service providers, and they value CDMOs that are flexible, transparent, and as invested in a program’s success as the developers themselves. By aligning incentives with its partners, Mabion can pursue high-impact therapies that might otherwise stall under a standard fee model, accelerating development timelines for critical new medicines.

This strategic shift toward deep collaboration reflects broader trends in biopharma outsourcing. Biotech want experts who will help navigate complex regulatory pathways, de-risk challenges, and proactively solve problems to speed promising biologics from the bench to the bedside. Mabion’s answer is to offer comprehensive solution with a highly engaged team, effectively co-creating solutions with clients. In some cases, we can share your risk to accelerate the development of innovative therapies. This level of partnership not only builds trust, but also enables unmet medical needs to be addressed by combining expertise and resources. It is a model geared toward faster breakthroughs, reflecting the mission of the EU Biotech Act, which aims to streamline innovation.

Crucially, Mabion’s co-development philosophy dovetails with the EU Biotech Act’s goals. The Act’s vision of faster clinical development and vibrant innovation ecosystems thrives on exactly this kind of close collaboration.⁴ By investing in state-of-the-art science and working with the urgency of clients’ pipelines, Mabion aims to set the pace in the CDMO sector. The company’s strategy explicitly blends classic service contracts with co-development deals, positioning Mabion to execute more advanced projects faster and with greater predictability. Mabion is evolving into a partner of choice for biotech innovators who are seeking to leverage the new pro-innovation climate.⁵ This approach not only increases the chances of securing new contracts in the EU Biotech Act era, but also helps bring life-changing biologic therapies to patients sooner – fulfilling the shared industry mission to address unmet medical needs. 

The new strategy sends a clear message: Mabion is accelerating. We are focusing on what creates real value for clients — technology, scalability, and a partnership-driven approach. We are entering high-growth segments and expanding capacity to execute more advanced projects, faster and with greater predictability.

Expanding Global Biotech Collaborations for Future Growth 

With an environment primed by the EU Biotech Act, Mabion is broadening its global reach and inviting biotech companies far and wide to partner in 2026. Thanks to our location in Poland, a part of the EU’s single market, Mabion offers cost-effective, high-quality manufacturing that appeals to both emerging biotechs and established biopharma companies.

In a market where financing is at a premium and every deadline counts, strengths such as “can-do” approach have made Mabion an attractive ally. Industry observers note that price and flexibility are playing an increasingly important role in the selection of CDMOs, and Mabion offers its customers better value for money, making it easier to adapt to current financial constraints without compromising on quality. By taking advantage of the favorable European policy framework and its own cost-effective infrastructure, Mabion enables its customers to make even greater use of their research and development budgets.⁶

Mabion’s capabilities span a wide array of biologic drug types and therapeutic areas, which is vital as biotechnology innovation accelerates. Biologic medicines like therapeutic antibodies and engineered proteins are now transforming patient care across many diseases. From oncology and immunology to neurology and rare diseases, biologics are unlocking new treatment options where traditional small molecule drugs often fell short. Mabion is well-positioned to support projects in all these fields, as the underlying development and manufacturing processes draw on the company’s core expertise. By maintaining high scientific and regulatory standards alongside agile project management, Mabion can adapt to the specific needs of each program. Our expectation ofscientific collaboration is higher than ever, and Mabion’s team of 200+ scientists, engineers, and experts works closely with clients to turn complex research ideas into tangible clinical products.

In terms of drug modalities, Mabion’s service portfolio covers all major biologic classes, aligning with where the industry’s innovation is booming. The company has decades of know-how in monoclonal antibodies (including biosimilars) and is now expanding into next-generation formats like antibody–drug conjugates (ADCs) and bispecific antibodies through strategic partnerships. It also supports the development of recombinant vaccine antigens and other therapeutic proteins, leveraging its robust mammalian cell culture and protein purification platforms. These areas are among the fastest-growing segments in biologics, and Mabion’s strategic roadmap confirms its commitment to them: new business initiatives are targeting biosimilar mAbs, ADCs, bispecifics, and other innovative biologics as key growth drivers. By broadening into these modalities Mabion can meet diverse client needs under one roof. Our capabilities from early cell line development and process optimization to large scale drug substance manufacturing eliminates inefficiencies associated with handing off projects between multiple vendors. Clients benefit from a seamless pipeline, speeding up progress while maintaining the highest quality across each stage.

As 2026 unfolds, Mabion is primed to help its partners harness the opportunities created by the EU Biotech Act and the growing global demand for biologics. The company’s vision is to be a trusted global partner for the development and manufacturing of biologic medicines, a mission that resonates even more strongly in the current pro-innovation climate. By strengthening its technological capabilities and championing a partnership-centric approach, Mabion is accelerating its evolution into a CDMO of choice in Europe.

The publication of the Biotech Act by the European Commission has set the stage for an era of rapid biotech advancement and Mabion is seizing this moment to support biotech innovators in bringing new biologic therapies to market. For companies developing the next wave of therapeutic proteins, collaborating with Mabion offers the chance to co-develop under an enabling framework, mitigate development risks, and ultimately deliver medical breakthroughs to patients worldwide.

FAQ

Prepared by:

Aleksandra Stasiak

Senior Registration Dossier Specialist

a.stasiak@mabion.eu

Aleksandra Stasiak

Senior Registration Dossier Specialist

Aleksandra has worked at Mabion since 2014 as a Regulatory Expert. She participated in technology transfer and scale-up to a commercial facility in Konstantynów Łódzki. Her experience includes working in the Quality Assurance team and the Regulatory Compliance and Consulting Department. She has also been involved in cell bank characterization, eCTD development and validation, and a new Phase III clinical trial.

Jakub Knurek

Marketing Specialist

j.knurek@mabion.eu

Jakub Knurek

Marketing Specialist

Jakub Knurek is a marketing and business development expert specializing in CDMO operations with scientific and biopharmaceutical background. During the COVID-19 pandemic, he contributed to the development of the Novavax protein vaccine. As a side project, he runs his own pharma company.

As the author of numerous articles, he is recognized as an important voice of the younger generation of scientists. He is a member of Mabion’s representation at industry trade shows, including BIO International Convention 2025 in Boston, 2nd Global Biologics India 2025 in Hydrabad, CPHI 2024 in Milan, CPHI 2023 in Barcelona, Life Sciences Baltics 2023 in Vilnius. He actively participates in academic, business and industry discussions, such as the “Building the Future Pharma Workforce” panel at CPHI Milan 2024.

References

1.  European Commission. Proposal for a Regulation to establish measures to strengthen the Union’s biotechnology and biomanufacturing sectors (European Biotech Act). 2025.
2. European Commission. New measures to make EU health sector more innovative, competitive and resilient. 2025. 
3. Gabrielczyk T. Biopharmaceutical sector welcomes EU Biotech Act. European Biotechnology. 2025.
4. Skentelbery C. A Biotech Act for Europe. EuropaBio. 2024.
5. Mabion Business Strategy 2025-2030.
6. Knurek J. Why Europe is Becoming a Global Hub for Biologics Manufacturing. Mabion Science Hub. 2025.
7. European Commission. Questions and Answers on the European Biotech Act. 2025.