Biosimilars Regulatory Services - Overview
Patent protections and the high cost of biological medicines have limited the availability of these medicines to the wider population and have failed to fulfill the unmet medical need of this population. As of 2020, patents for a significant number of biological molecules are expected to expire, and there seems to be a huge demand for biosimilar molecules, developed along lines similar to an already approved biological medicine (which is termed the ‘reference product/ ‘Innovator product’). A biosimilar product is expected to have similar quality, safety, and efficacy as that of the reference biological product. In the current Regulatory scenarios, vaccines and blood or plasma-derived products are not considered biosimilars.
Most of the biosimilar programs in the world are being developed considering the global commercialization plan. The factors that prove the bio-similarity of a biosimilar molecule in terms of an innovator molecule are:
- The type of expression system used to produce the biosimilar molecule (Prokaryotic or Eukaryotic expression system)
- The optimized manufacturing process utilized to produce desired biosimilar molecules with an acceptable impurity profile.
- The selection of reference medicinal products is based on the global commercialization plan.
- The study is designed for non-clinical studies to address certain developmental or quality related issues and to demonstrate comparability.
- The prospective planning for global clinical trials is based on the global commercialization plan.
Though a biosimilar applicant does not need to generate huge data similar to that of a new drug and can get data waivers for non-clinical and clinical sections, there will not be any data waivers for the CMC part of the Biosimilar product and the applicant needs to prove the comparability against the Innovator product with extensive Quality data. In addition, major Regulatory authorities such as the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the World Health Organization (WHO) and the Rest of the World (RoW), as well as Regulatory authorities from emerging countries having already established the biosimilar Regulatory framework, it is expected that proper planning of a Biosimilar program with the right Regulatory strategies will assure the successful global launch of biosimilar molecules.
Freyr has a well-established infrastructure and the right expertise to provide Regulatory services for all types of biosimilar products. We offer support in strategic planning for biosimilars right from the development stage. We also conduct Regulatory gap assessments and mitigation plans for identified Regulatory gaps as well as the preparation and submission of biosimilars Biological License Applications (BLAs)/ Marketing Authorization Applications (MAAs) and the registration of dossiers in the global market.
Biosimilars Regulatory Services - Expertise
Freyr has well established infrastructure and expertise to provide Regulatory support for marketing authorizations and life cycle management (LCM) of various biological products in the global market.
Freyr Regulatory experts have experience in all phases of a product life cycle (i.e., initial R&D stage, non-clinical studies, clinical studies, marketing authorization and post-approval LCM).
We believe that understanding Regulatory requirements in the right way is the key to success in today’s global market. It saves a company’s time, effort and investments.
Pre-submission Support and Guidance
- Strategic consulting and Regulatory support for submission of Marketing Authorization Applications (MAA)
- Product evaluation for suitability under expedited programs, and Regulatory support for submission of expedited program requests
- Product evaluation for suitability under Orphan Drug Designation, and Regulatory support for submission of Orphan Drug Designation requests
Regulatory Services for USA & Europe Regions
- Regulatory Gap analysis (review of product data) and preparation of Regulatory strategies to mitigate the identified Regulatory gaps.
- CMC writing for clinical trial applications and Marketing Authorization Applications (MAAs / BLAs)
- CMC query responses
- Product life cycle management
- Change controls management & CMC variations.
- Biological Master File services for submission of information about processes, methods, and other advanced technologies (e.g., gene sequencing techniques) that are proprietary in nature.
Regulatory Services for ROW Market (Asian, African, Latin America & CIS regions)
- Regulatory strategies, country-specific Regulatory gap assessment for biological products registration
- Compilation of product dossiers and query responses in country-specific format
- Change controls management & CMC variations.
- Product life cycle management
Regulatory Support for Biologics GMP Compliance (USA, Europe & ROW)
- Interpretation of current GMP requirements/ regulations for various biological products (GMO, recombinant proteins, cell cultured-based products, viral vaccines (live and inactivated) and supporting clients in designing GMP systems and procedures.
Regulatory Services for Vaccines Prequalification by the WHO
- Product gap assessment for WHO prequalification
- Regulatory strategies development for Vaccines Prequalification
- Compilation of Products Summary File (PSF) & query responses
- Handling of variations
- Prequalified Vaccines Annual Reports (PQVARs) submission
End-to-End Regulatory Services for Biological Products Launch in the Indian Market
Marketing authorization of a biological product in India follows a typical process and requires approval from various Regulatory entities like the Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Appraisal Committee (GEAC) and Central Drugs Standard Control Organization (CDSCO) depending on the nature and type of the product. Freyr provides end-to-end Regulatory support for development, marketing authorization and life cycle management of biological products manufactured in-house (within India), and products imported from outside India.
