Biological medicinal products are promising solutions in prevention and treatment of many life-threatening chronic diseases and health conditions that cannot be managed with normal pharmaceutical products (e.g. Diabetes, cancer, autoimmune diseases, microbial infections etc.).

Biological medicines are generally made from human and/ or biological materials through modern biotechnological methods such as recombinant DNA technology and advanced cell culturing. At present, majority of the biological products are produced using genetically engineered bacteria, yeast, fungi and mammalian cells with a multi-step process that involves advanced cell culturing, purification and characterization techniques.

Different types of biological medicinal products (but not limited to) are provided below:

  • Vaccines (e.g. DTP vaccine, Polio vaccine & Hepatitis B Vaccine)
  • Recombinant therapeutic proteins and Monoclonal antibodies (e.g. GCSF, Erythropoietin, Insulin, Infliximab, Etanercept, Bevacizumab & Rituximab etc.)
  • Blood and Sera products (e.g. Hunan Immunoglobulins, Anti snake venom, Anti tetanus toxin sera, Anti Diphtheria toxin sera etc.)
  • Cellular and Gene therapy products

Advantages of biological medicinal products:

  • Biological medicinal products act on specific system/cells/organs of the human body and show their efficacy with minimal /or acceptable adverse effects, which is normally not possible with other pharmaceutical products. This high specificity has become a great advantage in treating chronic diseases like cancer and autoimmune disorders.
  • Some of the biological products are used to manage health crisis that results due to deficiency of certain metabolic proteins / factors in the human body (e.g. Insulin and GCSF).
  • Specific or whole part of a microorganism is used as an immunological agent (vaccine) to induce active immunity in the human body. These products play a vital role in the prevention of many life-threatening diseases such as Polio, Pneumonia, Typhoid and Cholera.

Regulatory hurdles in approval of biological medicinal products

Due to the complexity of biological products, regulatory requirements for approval of these products vary based on the product type, and require submission of extensive data to support quality, safety and efficacy.

Globally, regulatory agencies evaluate biological products for approval on a case by case basis with a risk based approach, due to which fulfilment of regulatory requirements for biological medicinal products become a big challenge for the industry.

Freyr Capabilities

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 right way is the key to success in today’s global market. It saves a company’s time, efforts 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 US & EU 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 Application (MAAs / BLAs)
  • CMC query responses
  • Product life cycle management
  • Change controls management & CMC variations
  • Biological Master File services for submission of information about process, 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 compliances (US, EU & 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 client in designing GMP systems and procedures

Regulatory services for Vaccines Prequalification by 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 Indian Market

Marketing authorization of a biological product in India follows a typical process and requires approval from various regulatory entities like RCGM, GEAC and 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.

Freyr Advantages

  • Best-in-class CMC understanding with pharmaceutical dosage forms such as injectable (sterile solutions, powder for injections and pre-filled syringes)
  • Comprehensive evaluation of dossier from the assessor’s standpoint
  • Successful filing strategy with “first-time-right” outputs to ensure timely approvals
  • Evaluation of documentation as per the recurrent changes
  • Progressive functioning models
  • Global service delivery competence for advantageous cost alignments
  • Round-the-clock support
  • The concept of “first-time-right” outputs to ensure timely approvals

Companies may not realize it today, but biological medicinal products bring huge opportunities around the globe especially in the sustainable markets such as the US and EU regions and emerging countries like Mexico, Brazil, China, Russia, and India. Although the business scope for growth in this market is predicted to be of excellent value, the evolving regulatory aspects associated with it cannot be overlooked. For companies to expand their global footprints in new geographies, it is necessary to meet the regulatory requirements right on time. Companies should understand that if the opportunities are more, so are the regulatory challenges. Dedicated partners providing CMC services for biologics can rescue them from these uncalled hurdles with their years of expertise and steadfast solutions.