Daily Current Affairs : 29-July-2023

The field of medicine has witnessed tremendous advancements in recent years, especially in the development of biologics. These innovative drugs, known as biologics or biological products, are produced using living organisms through complex production procedures. They encompass a wide range of products, including vaccines, therapeutic proteins, monoclonal antibodies, and gene and cell therapies. To facilitate access to affordable and safe treatments, biosimilars, which are similar to reference biologic medications, have emerged as viable alternatives. In light of the rapidly evolving global landscape, the health ministry in India is planning to revamp guidelines for approving biosimilar drugs, aiming to create a more robust regulatory pathway.

Understanding Biologics and Biosimilars
  1. Biologics: Biologics are a class of medicines created using intricate production processes involving living organisms. They include vaccines, therapeutic proteins, monoclonal antibodies, gene, and cell therapies.
  2. Biosimilars: A biosimilar is a biologic that is “similar” to an already approved biologic medication, known as the reference product. Biosimilars are highly comparable to the reference products in terms of safety, purity, and potency, though they may have slight differences in clinically inactive components. Unlike generic drugs, which are identical to their reference small-molecule drugs, biosimilars are not exact replicas but close imitations of the reference biologics.
    • Biosimilars are produced using the same amino acid starting materials and procedures as the reference medicine.
    • Examples of biosimilars include Semglee (insulin glargine-yfgn), Amjevita (adalimumab-atto), and Inflectra (infliximab-dyyb).
    • Biosimilars offer a more cost-effective option compared to their original biologics, making them accessible to a broader population.
Prospects of Biosimilars in India

The emergence of biosimilars holds promising prospects for India’s pharmaceutical industry and healthcare system.

  1. Expanding Market: The market for biosimilars is on the rise due to their application in treating cancer, diabetes, and autoimmune diseases. This growth opens up new opportunities for biosimilar development globally.
  2. Investment in India: Numerous pharmaceutical companies in India are heavily investing in biosimilar research and development, bolstering the country’s biotechnology sector.
  3. Enhanced Treatments: The development of biosimilars, such as the biosimilar version of trastuzumab emtansine, which inhibits cancer cell growth and aids in its destruction, leads to more effective treatment options for patients.
  4. Affordability: Biosimilars’ lower cost compared to original biologics makes them a viable option for patients who might otherwise find the reference products unaffordable.
  5. Development Impact: Encouraging the manufacturing of biosimilars to treat non-communicable diseases like cancer, asthma, and arthritis can have a positive impact on India’s economic development.
Challenges in Biosimilar Development

While the prospects of biosimilars are promising, there are several challenges that need to be addressed:

  1. Lengthy Development Process: The development of biosimilars is a time-consuming process, taking up to six or seven years, which can hinder timely market access.
  2. Temperature Sensitivity: Biosimilars’ sensitivity to temperature necessitates distribution through a cold chain network, adding logistical complexities.
  3. Higher Development Costs: Unlike generic drugs, biosimilars require substantial capital expenditures for machinery, buildings, and other assets, making their manufacturing costs higher.
Regulation and Development of Biosimilars in India

The regulation and development of biosimilars in India fall under the purview of several key bodies:

  1. Department of Biotechnology (DBT): Responsible for promoting and regulating biotechnology research and development.
  2. Central Drugs Standard Control Organization (CDSCO): Governs the approval and quality control of drugs and cosmetics in India.
  3. Indian Council of Medical Research (ICMR): Conducts medical research and helps in formulating guidelines and policies.
  4. Institutional Biosafety Committee (IBC): Ensures biosafety and ethical considerations in research involving biologics.
  5. National Control Laboratory Biosafety Committee: Overlooks the safety aspects of biologic drugs.
Acts and Guidelines Governing Biosimilars

Several key acts and guidelines shape the regulation and approval process of biosimilars in India:

  1. Drugs and Cosmetics Act (1940): The primary law governing drugs and cosmetics in India.
  2. Drugs and Cosmetics Rules (1945): Provides rules for the implementation of the Drugs and Cosmetics Act.
  3. Environment Protection Act (1986): Ensures environmental safety in biologic research and production.
  4. Recombinant DNA Safety Guidelines (1990): Guidelines related to the safe use of recombinant DNA technologies in research.
  5. Guidelines for Preclinical and Clinical Data for rDNA Vaccines, Diagnostics, and Other Biologicals (1999): Provides guidelines for the development and testing of biologic products.
  6. CDSCO Guidance for Industry (2008): Offers guidance to the pharmaceutical industry on regulatory matters.

Important Points:

  • The health ministry plans to revamp guidelines for biosimilar drugs in India to improve the regulatory pathway and align it with global developments.
  • Biologics are medicines produced using living organisms and include vaccines, therapeutic proteins, monoclonal antibodies, and gene and cell therapies.
  • Biosimilars are biologics that are highly similar to reference products, offering cost-effective alternatives to original biologics.
  • Biosimilars are gaining traction in treating cancer, diabetes, and autoimmune diseases, providing new opportunities for the pharmaceutical industry.
  • Indian pharmaceutical companies are investing significantly in biosimilar development, fostering growth in the biotechnology sector.
  • Biosimilars like the trastuzumab emtansine version offer enhanced treatment options for patients.
  • Biosimilars are more affordable than original biologics, making them accessible to a broader population.
  • Development of biosimilars can have a positive impact on India’s economic development, especially for treating non-communicable diseases.
  • Challenges in biosimilar development include a lengthy process, temperature sensitivity, and higher development costs.
  • The regulation and development of biosimilars in India are overseen by various bodies, including DBT, CDSCO, ICMR, IBC, and National Control Laboratory Biosafety Committee.
  • Acts and guidelines governing biosimilars include the Drugs and Cosmetics Act, Drugs and Cosmetics Rules, Environment Protection Act, Recombinant DNA Safety Guidelines, Guidelines for Preclinical and Clinical Data for rDNA Vaccines, Diagnostics, and Other Biologicals, and CDSCO Guidance for Industry.
  • The health ministry’s efforts aim to promote biosimilar development, strengthen the pharmaceutical industry, and improve healthcare accessibility in India.
Why In News

The health ministry’s ambitious initiative aims to overhaul the approval guidelines for biosimilar drugs, bolstering the regulatory pathway to ensure utmost efficacy and safety in line with the ever-changing global healthcare landscape. By embracing cutting-edge advancements and international best practices, these reforms seek to expedite access to high-quality biosimilars while maintaining rigorous standards.

MCQs about Advancing Healthcare Access with Biosimilars

  1. What are biosimilars?
    A. Medicines created using living organisms
    B. Medicines that are identical to brand-new pharmaceuticals
    C. Medicines that are exact replicas of their reference products
    D. Medicines that are unrelated to biologics
    Correct Answer: A. Medicines created using living organisms
    Explanation: Biosimilars are medicines created using living organisms through complex production procedures. They are highly similar to reference products, offering cost-effective alternatives to original biologics.
  2. Why are biosimilars gaining popularity in the pharmaceutical industry?
    A. They are brand-new pharmaceuticals with unique formulations.
    B. They are more expensive than original biologics, attracting high-end markets.
    C. They offer cost-effective alternatives to original biologics.
    D. They have a longer development process compared to generic drugs.
    Correct Answer: C. They offer cost-effective alternatives to original biologics.
    Explanation: Biosimilars are gaining popularity because they offer cost-effective alternatives to original biologics, making treatments more affordable for patients.
  3. What is a key challenge in biosimilar development?
    A. Short development process requiring only a year or two.
    B. Minimal sensitivity to temperature during storage and distribution.
    C. High capital expenditures for machinery and facilities.
    D. Availability of abundant raw materials for production.
    Correct Answer: C. High capital expenditures for machinery and facilities.
    Explanation: A key challenge in biosimilar development is the high capital expenditures required for machinery and facilities, which makes their manufacturing costs higher.
  4. Which organization is responsible for regulating biosimilars in India?
    A. World Health Organization (WHO)
    B. Central Drugs Standard Control Organization (CDSCO)
    C. International Pharmaceutical Federation (FIP)
    D. Food and Drug Administration (FDA)
    Correct Answer: B. Central Drugs Standard Control Organization (CDSCO)
    Explanation: The Central Drugs Standard Control Organization (CDSCO) is responsible for regulating biosimilars and overseeing the approval and quality control of drugs and cosmetics in India.

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