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Cheaper Effective Alternatives to Expensive Biologics

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Introduction
 
A new drug is manufactured generally by innovator pharmaceutical companies after many years of research and development. The introduction of a new drug is a costly affair but it provides the manufacturing company the patent rights for the drug, which is usually for a period of 20 years during which no other companies can sell the drug. Upon patent expiry, other pharmaceutical companies can replicate the branded drug (same active ingredient, strength, dosage form, and route of administration as the reference drug and it must also be “bioequivalent”) and sell its generic version at a significantly lower price.
 
The Hatch-Waxman Act of 1984 was designed to minimize the cost of patient treatment, which enabled the pharmaceutical companies to produce generic products from off-patent drugs. Various analytical methods exist which demonstrate that generic products are chemically identical to its original branded drug.
 
Biologics are derived from living organisms such as monoclonal antibodies (trastuzumab, infliximab), soluble receptors (etanercept) and recombinant DNA technology products such as human insulin analogue and growth hormone. Biologics are complex molecules requiring close control for manufacturing. Furthermore, biologics are expensive molecules thus, require low cost therapies i.e. biosimilars – a similar but not identical copy of biologic drugs in terms of structures, clinical efficacy and safety. It is not possible to produce biosimilars which are identical to the reference biologic medicines due to:
 

  • complexity
  • requirements of sophisticated manufacturing processes
  • higher development costs

 
Introduction of a brand new drug can be done after establishing the efficacy and safety through various phases of clinical trials. In case of biosimilars, the biological activity and toxicity profiles are already known, which eliminate the need of undergoing intense clinical trials. The Biological Price Competition and Innovation Act was created in 2010, to promote the use of lower priced alternatives, and to encourage competition among innovator biological drugs, elucidating new pathways for development and approval of reference biological drugs.
 
The large molecule biosimilar products are quite expensive to be produced. More funds are saved in reducing the amount of clinical trials which are needed to prove that the medicine is safe and effective than reducing the manufacturing costs. Further, biosimilar developers who focus on proteins of higher complexity will be challenged to be compliant to the existing processes for proving optimum similarity. However, they require higher costs and highly developed manufacturing processes.
 

 
The development pathway of a biosimilar molecule is different from that of a reference biologic. The commercialization of a biosimilar product is faster than the reference biologic since there is no need to conduct extensive studies regarding its safety, efficacy, risk management, epidemiology and health outcomes as these have already been completed for the reference biologic. Furthermore, the cost of the biosimilar molecule must be comparatively low than the reference biologic.
  
Indian Scenario 

India has witnessed immense growth as far as its biosimilar portfolio is concerned. The vaccine for hepatitis B was the first biosimilar in India, which was marketed and approved in 2000. The Indian Guidelines were developed which acknowledges the pre-marketing and post-marketing regulatory requirements along with the manufacturing process and quality control for biosimilars. About 100 biopharmaceutical companies are engrossed in research and development, manufacturing and marketing of biosimilar products in India.
 
Biosimilar approval process in India
 

Product development
  • Approval from Institutional Biosafety Committee
  • Approval from Department of Biotechnology (DBT)
Pre-clinical studies

  • Study to be conducted as per Good Laboratory Practices
  • Protocol to be designed as per schedule Y and approved by Review Committee on Genetic Manipulation and DBT
Clinical trial
  • Protocol approved by Drug Controller General of India (DCGI) and Ethics Committee
  • Manufacturing license is needed along with certificate of Good Manufacturing Practices
Marketing and Manufacturing License
  • Clinical trial report to be submitted to DCGI and dossier to be approved by DCGI
  • After the inspection of facility, manufacturing license is issued
Testing by National Institute of Biologicals
  • First three batches to be tested
Post approval
  • Post-marketing surveillance mandatory for at least 4 years
  • Safety reporting to DCGI every 6 months for 2 years
  • Process change needed to be approved by DCGI

 
[Paul P, Popoli H, Saxena A, Jaiswal A, Sah S. Current scenario of biosimilar. The Pharma Innovation. 2018; 7(7): 188-193.]

The establishment of a clear process for the development and approval of biosimilars has provided the gateway to improve patient access to biologics, increase treatment options, generate savings and efficiencies for the healthcare system.

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