The Language of Biologics: Why Translation Matters
Biopharmaceuticals—also known as biologics—are complex, large-molecule drugs derived from living organisms and used to treat chronic and life-threatening conditions such as cancer, autoimmune disorders, and rare diseases. Biosimilars are highly similar alternatives to these originator biologics, developed post-patent to expand access to life-saving treatments at lower cost.
As the global demand for biologics and biosimilars grows, so does the need for precise, technically accurate translation across every phase of the product lifecycle—from regulatory submissions and clinical trials to manufacturing, labeling, and commercialization. Regulatory agencies like the FDA, EMA, and PMDA require compliant, scientifically accurate multilingual documentation. Even minor translation errors can delay approvals, compromise quality assurance, or result in noncompliance.
At Sesen, we specialize in life sciences translation with deep expertise in biopharmaceuticals and biosimilars. Our linguists combine subject-matter knowledge with regulatory insight to deliver high-quality translations that support global product launches, ensure patient safety, and accelerate time to market. With Sesen, language is never a barrier to innovation.
Biologics Fluency Backed by Regulatory Precision
At Sesen, we bring unmatched subject-matter expertise to every biopharmaceutical and biosimilar translation project. Our team has deep, working knowledge of the entire biologics development lifecycle—from cell line engineering and preclinical studies to post-market surveillance—ensuring that every document we translate reflects scientific accuracy and regulatory readiness.
We understand the unique challenges associated with biosimilar development, including the need for comparative clinical and analytical data, and the complexity of global regulatory pathways. Our linguists and reviewers stay current with evolving guidelines from key authorities including the EMA, FDA, PMDA, Health Canada, and NMPA (formerly CFDA). Whether you’re preparing a Biologics License Application (BLA) or submitting documentation for biosimilar approval under the FDA’s Biologics Price Competition and Innovation Act (BPCI Act), Sesen delivers language solutions that meet country-specific standards.
Our translators hold advanced degrees in molecular biology, biotechnology, pharmaceutical sciences, and regulatory affairs, enabling them to accurately interpret highly technical source content and apply precise scientific terminology in over 100 languages. Every translation undergoes rigorous linguistic and regulatory QA to support global filings, audits, and commercialization activities.
With Sesen, you gain a specialized partner who understands both the science and the regulation behind your biologics pipeline—helping you reduce risk, accelerate timelines, and confidently engage global markets.
Types of Biopharma and Biosimilar Content We Translate
Sesen delivers end-to-end translation support across the entire lifecycle of biopharmaceutical and biosimilar products. From early-stage regulatory filings to post-market safety monitoring, our language services cover all essential documentation required for global development, approval, and commercialization. We translate highly specialized scientific and regulatory materials with accuracy, speed, and consistency—ensuring your content is always submission-ready and market-appropriate.
Regulatory Documentation
Our expert linguists translate high-volume, complex regulatory content aligned with ICH and regional health authority standards.
- Common Technical Document (CTD) Modules 1–5
- Investigational New Drug (IND) applications
- Biologic License Applications (BLA)
- Risk Management Plans (RMPs)
- Summary of Clinical Efficacy and Safety
- Regulatory briefing documents and agency responses
Clinical Trial Materials
We provide precise, patient-safe translations for clinical documentation to support global biosimilar trials.
- Study protocols and investigator brochures
- Informed consent forms (ICFs) in multiple languages
- Case report forms (CRFs) and eCRFs
- Patient recruitment materials and study diaries
- Ethics committee submissions
Manufacturing and CMC Content
Our translation services cover critical manufacturing documents to support quality, reproducibility, and regulatory approval.
- Chemistry, Manufacturing, and Controls (CMC) documentation
- Master batch records and standard operating procedures (SOPs)
- Method validation and analytical testing reports
- Quality assurance and GMP compliance documents
- Stability data reports and process validation files
Marketing Authorization and Commercialization
We help clients localize product communications for global launch while maintaining regulatory and linguistic accuracy.
- Product labeling, packaging, and carton content
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflets (PILs) and Instructions for Use (IFUs)
- Multilingual marketing collateral and sales training materials
- Promotional review committee (PRC) documentation
Post-Market Surveillance & Pharmacovigilance
Our team supports ongoing safety compliance through high-accuracy translations of pharmacovigilance and risk communication content.
- Adverse event (AE) and serious adverse event (SAE) reports
- Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Risk minimization measures (RMMs) and Dear Healthcare Provider (DHCP) letters
- Safety narratives and aggregate reports
With Sesen, you gain a trusted translation partner that understands the scientific and regulatory nuances of biopharmaceutical and biosimilar development—delivering accurate, high-quality multilingual content to support your global success.
ISO-Certified Quality for Regulatory-Grade Translation
At Sesen, quality is embedded in every step of our translation process. Our life sciences translation workflows are built on internationally recognized standards to support regulatory compliance, patient safety, and product integrity in every target market.
We are certified under:
- ISO 17100 – Translation Services: Ensures that all translations are performed by qualified linguists, reviewed by independent experts, and managed under strict quality control processes.
- ISO 9001 – Quality Management Systems: Governs consistent project execution, customer satisfaction, and continuous process improvement.
- ISO 13485 – Medical Devices: Applied when translating content related to drug-device combination products, ensuring alignment with global regulatory expectations.
Sesen’s QA/QC workflows include multistep linguistic review, terminology validation, and back-translation where required by regulatory authorities or client protocols. Each project is supported by customizable quality assurance plans tailored to the document type, target audience, and country-specific requirements.
We also maintain full compliance with global data protection and digital documentation standards, including:
- GDPR – For secure handling of personal and clinical trial data within the EU
- 21 CFR Part 11 – For electronic records and signatures under FDA oversight
By partnering with Sesen, you gain a translation provider that meets the same high standards expected of your biopharmaceutical and biosimilar products—ensuring trust, consistency, and regulatory alignment at every stage.
Specialized Linguists with Deep Regulatory Insight
Our linguists combine linguistic fluency with in-depth knowledge of the science, regulatory environment, and cultural context driving biopharmaceutical and biosimilar development.
Each Sesen translator is carefully selected for their expertise in biotechnology, molecular biology, pharmacology, and regulatory affairs, ensuring the highest level of precision across highly technical content. Our multilingual teams have in-depth knowledge of international and region-specific regulatory guidelines, including ICH, EMA, FDA, WHO, PMDA, Health Canada, and other national health authorities.
To further strengthen accuracy and compliance, Sesen employs in-country reviewers who are familiar with local terminology standards, health authority expectations, and cultural nuances. This localized review ensures that your documents are not only linguistically accurate, but also regulatory-ready and culturally appropriate for each target market.
With Sesen, you benefit from a highly specialized linguistic team that bridges scientific complexity and global compliance—ensuring that your biologics and biosimilars are understood, approved, and trusted worldwide.
Technology-Enabled Human Translation, Purpose-Built for Biologics
At Sesen, we combine the precision of expert human linguists with advanced language technology to deliver scalable, high-quality translations for the biopharmaceutical and biosimilar sectors. Our technology-enabled workflows enhance consistency, reduce turnaround times, and support compliance—without compromising scientific or regulatory accuracy.
We leverage translation memory (TM) and centralized terminology databases to maintain consistency across recurring technical terms, regulatory language, and product-specific nomenclature. This is especially critical for large-volume documentation such as CTD submissions, clinical trial data, and global labeling.
For cost-sensitive or high-volume projects, Sesen offers a Hybrid Translation model—machine translation post-editing (MTPE) enhanced by domain-expert linguists and layered with rigorous human quality assurance. This approach supports faster timelines while upholding regulatory-grade precision.
All projects are managed within Sesen’s secure, AWS-hosted translation management system, which enables real-time collaboration, version control, and end-to-end project visibility. Our platform is designed to support enterprise-level biopharma workflows with full audit trails and encrypted data handling.
With Sesen, you gain a partner that merges linguistic expertise with modern translation technologies—accelerating global submissions while safeguarding quality, security, and scientific integrity.
Global Language Coverage for Worldwide Biologics Access
Sesen supports biopharmaceutical and biosimilar companies in achieving seamless global communication across regulatory, clinical, and commercial operations. With translation capabilities in 150+ languages, we help clients navigate the complexities of international compliance, accelerate product launches, and expand access to life-saving therapies worldwide.
Our linguistic teams have supported multinational biologics and biosimilars programs across the European Union (EU), Latin America (LATAM), Asia-Pacific (APAC), and the Middle East and North Africa (MENA) regions. We’re experienced in managing multilingual documentation aligned with regional health authority standards, including EMA, FDA, PMDA, NMPA, and ANVISA.
Sesen offers full localization support for multilingual drug launches, including labeling, packaging, patient information, and commercial assets tailored to each target market. Whether preparing biosimilar submissions for multiple jurisdictions or coordinating simultaneous global rollouts, our scalable workflows and in-country linguistic teams ensure speed, consistency, and compliance at every stage.
By partnering with Sesen, you gain a global translation provider uniquely positioned to support the cross-border demands of modern biopharmaceutical and biosimilar development.
Proven Success in Biosimilar Translation Projects
Sesen has supported global life sciences companies in launching biosimilar therapies across regulated and emerging markets. Our deep subject-matter expertise, regulatory fluency, and scalable translation workflows have enabled clients to meet tight submission deadlines and secure timely market entry.
Case Example: Multilingual Translation for EMA Biosimilar Approval
A leading global pharmaceutical company engaged Sesen to manage the multilingual translation of regulatory and clinical documentation for a biosimilar monoclonal antibody seeking EMA approval. The scope included over 1.2 million words across 12 languages, covering CTD Modules 1–5, Risk Management Plans (RMPs), SmPCs, and Patient Information Leaflets (PILs).
Sesen assembled a team of specialized linguists, in-country reviewers, and project managers to ensure full compliance with EMA language requirements and formatting guidelines. Using our AWS-hosted translation management system with built-in terminology and version control, we delivered all translations on time within a 6-week regulatory window.
Outcome
- EMA approval secured without language-related delays
- Product launched across 12 European markets within the planned timeline
- 100% compliance with linguistic validation requirements
This project reflects Sesen’s ability to deliver regulatory-grade translation at scale—empowering global biosimilar success through language precision.
Why Leading Biopharma Companies Choose Sesen
Sesen is a trusted partner for biopharmaceutical and biosimilar translation services, delivering a powerful combination of scientific expertise, regulatory precision, and global scalability. Our end-to-end solutions are built to support the highly technical and compliance-driven demands of biologics development across multiple markets.
Deep Biotechnology Expertise
Our linguists and subject-matter experts specialize in molecular biology, bioanalytics, immunotherapy, and biosimilar comparability—ensuring accurate, contextually relevant translations across every stage of product development.
Regulatory-Grade Translation Quality
We provide high-accuracy translations that meet stringent standards set by the FDA, EMA, PMDA, and other global authorities. Every document is validated through multi-step QA, in-country review, and ISO-certified workflows.
Scalable Language Solutions for Global Expansion
With support for 150+ languages and experience across diverse therapeutic areas, Sesen helps accelerate time-to-market for global drug launches, clinical trials, and regulatory filings—without compromising consistency or compliance.
Dedicated Project Managers and Flexible Workflows
Each engagement is led by a seasoned project manager who coordinates timelines, quality checks, and client communication. Our workflows are fully customizable to integrate with your internal systems and adapt to your evolving needs.
From initial IND applications to post-market pharmacovigilance, Sesen delivers specialized translation solutions that move your biopharmaceutical and biosimilar products forward—efficiently, globally, and with confidence.
