Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
Biosimilars & Vaccines
Regulatory Support

Biosimilars & Vaccines Regulatory Support

GMP gap assessment, Compliance advice and Bridging support, QMS documentation, Facility upgradation advice, Mock up audit, QP audit, EU GMP inspection-to-certification hand holding, Annual report submission.

Our Expertise in Biosimilars & Vaccines

  • Skilled resources with core biopharmaceutical industry experience, having in-depth understanding of biologics (biosimilars and vaccine) development processes and regulatory requirements at different phases of product life cycle
  • Technical competencies to support regulatory activities related to different recombinant expression systems and mammalian cell lines (E.Coli, Yeast rCHO etc.) for biosimilar product development and various platform technologies (egg based, cell based, recombinant) for vaccine development
  • Specialized team for regulatory CMC authoring including upstream and downstream processes, scientific writing of dossier, review and submissions, addressing deficiency responses from various Health Authorities
  • Expertise in generating biosimilar and vaccine intelligence reports
  • Strong connect with regulatory and marketing experts across BRICS-TM countries, ACCESS countries, Asia, Africa (including MENA), GCC and Latin America
  • Hands on experience on some of the representative molecules such as Bevacizumab, Adalimumab, Trastuzumab, Denosumab, Peg-aspargase, Liraglutide, BCG, Influenza and others

Where can Metina support?

  • Regulatory guidance on upstream and downstream process development (DS) and product development (DS & DP) for biosimilars & vaccines
  • Review and advice for establishing biosimilarity – CMC, analytical comparability protocol (physicochemical & biological characterization), setting specification, validation, stability studies etc.
  • Regulatory advice on vaccine development
  • Regulatory support for technology transfer package – review of package, gap identification etc.
  • Support for pre-submission advisory meetings/ Scientific advice packages, agency meetings
  • Guidance and review of non-clinical study protocols & reports, authoring Dossier sections
  • In vitro – Functional assays, receptor binding assays, cell based assays
  • In vivo – PK/PD, Comparative repeat dose toxicity, Immunogenicity (dose, dosing regimen, ROA) and Local tolerance studies, Challenge studies
  • Guidance and review of Phase I (PK/PD) clinical study protocol & report
  • Support for pre-submission advisory meetings/ Scientific advice packages
  • Guidance and review of Phase II clinical study protocol & report (evaluating short-term side effects & immune responses)
  • Support for pre-submission advisory meetings/ Scientific advice packages
  • Guidance and review of Phase III clinical study protocol & report
  • Support for pre-submission advisory meetings/ Scientific advice packages
  • Authoring/ Compilation/ review of Non-clinical section of the dossier [Module 2 (2.5, 2.7), Module 5]
  • Regulatory Gap assessment of the dossier
  • Detailed review of all official applications to regulatory agency
  • Dossier submission (authoring/ compilation, review and submission) support for registration in BRICS-TM, WHO & other RoW markets, Regulated markets
  • Dossier submission (authoring/ compilation, review and submission) in regulated markets (US, EU, Australia, Canada, Switzerland)
  • Addressing queries from health authorities
  • Representing MAA review committees at agency level
RDC 55/2010, ANVISA

BRICS-TM GUIDELINES

FP Guide -Russian Federation

BRICS-TM GUIDELINES

Guidelines on Similar Biologics - CDSCO

BRICS-TM GUIDELINES

Evaluation of Biosimilars - NMPA

BRICS-TM GUIDELINES

Biosimilar Medicines - SAHPRA

BRICS-TM GUIDELINES

Biosimilar Medicinal Products - TITCK

BRICS-TM GUIDELINES

NOM 257, SSAI-2014,COFEPRIS

BRICS-TM GUIDELINES

BRICS-TM countries

End-to-end regulatory support for MAA submission in Brazil, Russia, India, South Africa, Turkey, Mexico

  • Regulatory guidance on compliance to current regulations across BRICS-TM, gap assessment and devising regulatory strategy
  • Support for dossier preparation, review and submission in BRICS-TM countries
  • Evaluation of applications for registration of biological medicines, including;
    1. Review of dossiers for registration of biological medicines
    2. Handling all matters relating to biological medicines during review of applications for registration
    3. Addressing queries from regulatory agencies and supporting product registration
  • Evaluation of applications for amendments to registered biological medicines
  • GMP inspection and compliance support
  • MA holding and life cycle management

INDIA Regulatory Support

As a registered client on on TGA eBS portal, Metina can provide the following services additionally to its clients:

  • End-to-end regulatory support including licensure for import/export, test, examination, manufacture and approval – Form 10, 28D, 29, 46, etc.
  • RCGM submissions/approval (IBK Portal) – Preparation of packages for Preclinical studies permission & approval (Form C3/C4), Submission & approval of preclinical study report (Form C5/C6)
  • DCGI submissions (SUGAM portal) – Phase 1, Phase 2 and Phase 3 CTA submission package (as per New Drug Clinical Trial Rules, 2019) (Form 44)
  • MAA submission support – CTD authoring/compilation, review and submission (Form 27D/28D)
  • Regulatory support for filing of variations/amendments
  • MA holding and lifecycle management
  • Support for sample testing for biosimilar products and vaccines (CDL, Kasauli)

WHO Prequalification Programme & Other ROW/ Emerging Markets

Submission to WHO Prequalification programme (PQP) for Biologics

Based on Stringent regulatory agency (SRA) approval:

  1. Full assessment pathway
  2. Abridged assessment pathway

GMP inspection/ Sample analysis (depends on the filing pathway)

Product dossier assessment
by WHO

Products assessed and placed in WHO’s list of prequalified medicines

Accelerated registration in other low-and-middle-income countries (LMICs)

Enables procurement by many NRAs and other UN agencies

Regulatory Support from Metina

  • Regulatory advice and complete regulatory support for application to WHO PQP in compliance with WHO-PQP product specific guidelines & other guidance documents under WHO Technical Report Series
  • WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Rituximab and trastuzumab, Version 10, February 2020
  • WHO Pilot Procedure for Prequalification of Biotherapeutic Products: Human Insulin, Version 10, February 2020
  • Procedure for assessing the acceptability, in principles, of vaccines for purchase by United Nations agencies (2013); WHO Technical Report Series, No. 978, Annex 6
  • Support for GMP inspection/ compliance and sample testing
  • End-to-end regulatory support for filing to other ROW markets based on prequalification by WHO

Regulated Markets - US & EU

  • Regulatory strategy and gap assessment for biologic/ biosimilar development for US & EU
  • Regulatory support for BLA filing under 351(k) pathway of the PHS Act- authoring, review and submission
  • Regulatory support for MAA submission via Centralized procedure under Article 10(4) application – authoring, review and submission
  • Pre-submission guidance and support for preparation of briefing packages (BPD meetings) and scientific advice packages
  • Preparation for pre-IND/ scientific advisory meetings and support for IND/IMPD package preparation and submission
  • Support for GMP inspection

GMP Compliance Support for Biological Facilities

  • Support for EU GMP and PIC/S GMP inspection (Via NPRA, Malaysia)
  • GMP upgradation advice for biologics/ biosimilar manufacturing sites
  • Gap Analysis, Auditing and Report
  • Inspection Readiness Support
  • Preparation of GMP inspection application
  • Support throughout Inspection, CAPA, approval & renewal

Publications

Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization

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Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA & Canada

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Supplementary Table-1:
List of authorized mAb biosimilars in each country between 2013-2018

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Poster: Comparative evaluation of mAb biosimilar development and licensing regulations in BRICS-TM market

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