A biosimilar is a biologic medicine that is highly similar to an approved reference (innovator) product. Biosimilars offer a cost-effective alternative for treating a wide range of conditions, including cancer, autoimmune disorders and age-related diseases. Regulatory agencies require a stepwise development approach for biosimilars, in which extensive comparative analytical characterization forms the foundation for subsequent nonclinical and clinical justification.
Biologics and biosimilar development are complex, costly and highly regulated. Regulatory agencies require a stepwise development approach for biosimilars, in which extensive comparative analytical characterization forms the foundation for subsequent nonclinical and clinical justification. For both innovator biologics and biosimilars, demonstrating critical quality attributes consistently across the development lifecycle is essential to regulatory approval and commercial release.
We deliver a full package of biologics and biosimilar testing services to cGMP standards, covering analytical characterization, biosafety and quality control. Our integrated global network supports comparative analytical assessment at every stage of development, helping you manage risk, maintain compliance and progress through regulatory milestones.
Support biologics and biosimilar programs across the development lifecycle
- Demonstrate biosimilarity to reference products
Generate detailed comparative data on critical quality attributes, including physicochemical, structural, impurity, aggregate and functional comparability.
- Support regulatory approval pathways
Apply phase-appropriate testing aligned with global regulatory expectations, supporting comparability and biosimilarity strategy from early analytical characterization through to commercialization.
- Manage development risk and cost
Access customized testing programs and integrated capabilities designed to reduce duplication, manage cost and support efficient progression through development.
- Expand capacity through outsourcing
Use our global laboratory network to scale analytical capacity without additional infrastructure investment.
- Maintain quality across the lifecycle
Cover discovery, preclinical work, clinical phases I–III, routine production, market release and lifecycle stability through a single, integrated provider.
- Support a wide range of biologic modalities
Apply analytical capabilities to therapeutic proteins, monoclonal antibodies, cell and gene therapies, plasmids, viral vectors, vaccines and biosimilars.
Discover our biologics and biosimilar testing services
- Comparative analytical characterization for biosimilars
We deliver early-phase characterization and late-stage comparability testing to demonstrate similarity to the reference product across critical quality attributes.
- Innovator biologics characterization
We support discovery and preclinical development of innovator biologics with analytical characterization aligned to product type and stage, applicable across therapeutic proteins, monoclonal antibodies, cell and gene therapies, plasmids, viral vectors and vaccines.
- Method development, transfer and validation
We develop, transfer and apply phase-appropriate validation to analytical methods, supporting consistency across sites and progression through development phases.
- Forced degradation and stability-indicating studies
We perform forced degradation studies and stability-indicating method work to support product understanding, shelf-life determination and regulatory submissions.
- Batch release and stability testing
We deliver routine batch release and stability testing for drug substance and drug product to cGMP standards, supporting clinical and commercial supply.
- Comparability and biosimilarity strategy support
We provide strategy support aligned with regulatory scientific advice, helping define analytical approaches for comparability assessments and biosimilarity demonstrations.
Why SGS?
As the world’s leading testing, inspection and certification company, we bring over 40 years of experience in biologics, supporting both innovator developers and biosimilar manufacturers across the development lifecycle. Our integrated laboratory and clinical expertise, combined with dedicated project management and regulatory support, enables coordinated delivery across complex programs.
Our global network spans North America, Europe and Asia-Pacific, providing customized testing programs and analytical capacity at scale. This combination of cGMP-compliant capabilities, scientific rigor and regulatory expertise supports the development of safe, effective and high-quality biologic therapies.
FAQs
We deliver a full package of biologics and biosimilar testing services to cGMP standards, covering analytical characterization, biosafety and quality control. Our services span comparative analytical assessment, method development and validation, forced degradation and stability-indicating studies, and routine batch release and stability testing for drug substance and drug product.
We support every stage of biologics and biosimilar development, from early research through commercialization, including:
- Discovery and preclinical development for innovator biologics
- Analytical characterization and comparative assessment of the reference product for biosimilars
- Clinical phases I–III
- Routine production and market release
- Lifecycle management and stability
Our services apply to a wide range of biologics, including therapeutic proteins, monoclonal antibodies, cell and gene therapies, plasmids, viral vectors, vaccines and biosimilars.
Comparative analytical studies are central to biosimilar development. We provide both early-phase characterization and late-stage comparability testing to demonstrate similarity to the reference product. Our studies generate detailed insight into critical quality attributes (CQAs), including:
- Physicochemical and structural attributes
- Product- and process-related impurities and aggregates
- Biological activity and functional comparability
We support method development, transfer and phase-appropriate validation aligned with stage of development. This includes forced degradation and stability-indicating studies, alongside routine batch release and stability testing for drug substance and drug product.
We combine more than 40 years of experience in biologics testing with an integrated global network across North America, Europe and Asia-Pacific. Our advantages include:
- Customized testing programs tailored to your product and stage
- Method development, transfer and validation
- Integrated laboratory and clinical expertise
- Dedicated project management and regulatory support
- Comparability and biosimilarity strategy support aligned with regulatory scientific advice