Overview

Generic and Innovator drugs bear many similarities, and their difference is mainly one of pricing.  A generic drug has the same dosage, safety, effectiveness, strength, stability, quality and performance characteristics as an innovator drug. It is also consumed in a manner similar to an innovator drug. However, it is far more economical when compared to an Innovator drug. With an objective to produce high quality pharmaceutical formulations, generic drug manufacturers strive to identify the most critical needs of patients across the globe, and devoting their resources to meeting those needs by developing safe, effective and affordable healthcare solutions.

Innovators are protected by patents and exclusivities that influence how and when a generic drug can be approved and marketed. These patents, usually issued by the Patent and Trademark Office, protect the Innovator drug manufacturers by prohibiting others from selling generic versions of the same drug. Periods of marketing exclusivity for innovator drugs can also impact the approval of generic drugs. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the generic drug can receive full approval, and can be distributed and made available to the public.

Generic drugs tend to more cost-effective when compared to innovator counterparts because they do not have to repeat animal and clinical (human) studies that were required of the innovator drug companies to demonstrate safety and effectiveness. In addition, multiple applications for generic drugs are often approved to market a specific product, and this creates competition in the marketplace, typically resulting in lower prices.

The reduction in upfront research costs means that although generic medicines have the same therapeutic effect as their innovator counterparts, they are typically sold at substantially lower costs, as non-clinical and clinical studies are unnecessary for the generic company and only pharmaceutical equivalency needs to be proven, instead. When multiple generic companies market a single approved product, market competition typically results in prices that are about 85% lesser than those of the innovator.

Regulatory affairs play a central role in the various phases of generic drug production which are: development, manufacturing, registration and life cycle management. The role of Regulatory affairs is to guide the manufacturer, so that the generic product is developed, manufactured and registered in accordance with country-specific requirements.

Freyr, a leading Regulatory services provider, has the experience and expertise required to handle the different phases of product registration from development to life cycle management. Following are some of the interesting facts about Freyr’s deliverables:

  • Compilation, review and submission of about 40 Abbreviated New Drug Applications (ANDAs) to multiple clients and have not received Refuse-to-Receive (RTR) for even one ANDA
  • End to end Regulatory support provided for generic manufacturers from development stage of the product to post-approval submissions and life cycle management
  • About 100 Market Authorization Applicaitons (MAAs) to Europe countries by Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) and National procedures
  • Compilation/Conversion (paper format to electronic Common Technical Document [eCTD]) and submission of about 100 Durg Master Files (DMFs) to the United States Food and Drug Administration (USFDA) and Health Canada and the European Medicines Agency (EMA)
  • Every year, Freyr supports clients with Regulatory strategy, submission planning, compilation and submission of supplements/ amendments/ variations for proposed major changes (About 100), Moderate Changes (About 300) and minor changes (About 800) to the approved ANDAs/MAAs/ANDSs/Dossiers
  • Every year, Freyr supports clients with the submission of life cycle management activities like Annual Reports (About 750) and Renewals (About 1000) with tracking, follow-up for additional documents, compilation and submission for already approved ANDAs/MAAs/ANDSs/Dossiers/DMFs/CEPs

Freyr Expertise

Development Stage:

  • Prototype formula clearance for IIG (If required Clearance Certificate (CC) can be filed with FDA)
  • Quality by Design (QbD) protocol & report review
  • Final formula clearance with respect to IIG, dose proportionality, size and shape
  • Support in finalization of API, excipients and packing material specifications and test methods
  • Product development report review
  • Review guidance in stability protocol, hold time protocol, process validation protocol and master formula record
  • Support in finalization of In-process and finished product specifications and test methods
  • All method validation and verification/transfer reports
  • Guidance on Bio-study and stability study
  • Guidance on setting the limits for genotoxic and elemental impurities

Pre-submission Administrative Activities

  • Request for ANDA Number and labeller code
  • Request for Facility self-identification, DUNS number, FEI number

Regulatory Assessment/Gap Analysis

  • Gap analysis for source documents/data
  • Preparation of assessment report and guidance for remediation
  • Regulatory assessment of master dossier against country-specific requirements for registration

Compilation, Review & Submission

  • Compilation of modules as per the CTD and country-specific submission requirements
  • Technical review of the compiled CTD sections
  • Finalization and submission of complete dossier to agencies

Response to Queries

  • Regulatory assessment/gap analysis of the queries/information requests
  • Finalising the strategy in the preparation of response to queries
  • Coordination with client for generation of data
  • Compilation, review of the response documents with scientific/logical inputs
  • Submission of the response document

Submissions for Post-Approval changes

  • Evaluation of change controls (for site transfers, manufacturing process changes, supplier changes, extension of retest period/expiry, change in batch size, container closure system changes, etc.) along with supporting documents
  • Preparation of post approval submission strategy
  • Guidance to client on submission strategy
  • Guidance on additional documents/data generation/requirement
  • Compilation, review and submission of post-approval changes package (Supplements/Amendments/Variations)

License Cycle Management Services

  • Tracking of the due dates of ARs/Renewals via the tracker
  • Guidance to the client on the submission strategy of the ARs/Renewals
  • Compilation, review and submission of ARs and Renewals on scheduled time for product registrations across the globe (i.e., United States, Canada, Europe (EU), Australia, Asia Pacific (APAC), Africa, Commonwealth of Independent States (CIS), Middle East and North Africa (MENA), Latin America (LATAM) etc.)
  • License tracking & management