Case Study: Clinical Development Programme and the India Biosimilar Market

The biosimilar market is one of high growth potential for many large pharmaceutical companies, generic manufacturers, biotechnology companies and new market entrants worldwide.

The Indian biosimilar market has demonstrated robust growth over the past few years, placing India in a position of leadership in the global market. The low-cost manufacturing capability of India-based companies is a definite attraction to pharmaceutical companies striving to achieve cost efficiencies. However, there are additional factors that can influence the decision to choose a global player to help conduct clinical trials in India.

Study design

A leading Indian pharmaceutical company approached Fisher Clinical Services, Ahmedabad, to support its clinical development programme. As this was a complex study, a dedicated team was set up with representatives from the Indian sponsor and from the Fisher Clinical Services team at Ahmedabad, to review all aspects of the Sponsor’s biosimilar study including:

  • Study design
  • Regulatory requirements
  • Comparator sourcing strategy
  • Blinding techniques
  • Labelling
  • Storage capacity, particularly cold chain
  • Distribution and logistics

Comparator sourcing

Comparator Sourcing was a key component of the sponsor’s clinical development programme. The Comparator Center of Excellence team at Fisher Clinical Services was best placed to assist the Sponsor in developing a sourcing strategy for innovator reference products for this trial.

Defined processes to check for counterfeit products and the application of stringent sourcing strategies assured the sponsor of the authenticity of comparators sourced by Fisher Clinical Services.

Regulatory compliance

One regulatory requirement in India is that investigational medicinal products (IMP) can only be imported into India once clinical trial approval has been granted. However, as Fisher Clinical Services Ahmedabad is located in a Free Trade Zone, this is deemed as foreign territory, which facilitates the import of IMP into this zone for storage until the clinical trial has been approved.

In this instance, the sponsor chose to store its IMP at Fisher Clinical Services so that it was ready for distribution immediately once clinical trial approval was granted.

Free trade zone

The strategic location of Fisher Clinical Services in a Free Trade Zone offered many advantages to the Sponsor:

  • Ability to bring comparator products to the Fisher Clinical Services Ahmedabad facility with ease, without the need for an import licence
  • No import / export taxes applicable to these comparator products

GMP Facilities

Fisher Clinical Services, Ahmedabad, is one of the only facilities in the Asia-Pacific that is fully audited and approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for clinical trial packaging.

In addition, patented blinding techniques assured the sponsor that clinical trial materials would not be compromised in any way across the supply chain. The sponsor chose to work with Fisher Clinical Services due to its good manufacturing practice (GMP) compliant systems and processes, a real differentiator in the region.

Supply chain risk mitigation

It was of utmost importance for the sponsor to have full visibility of all clinical trial materials in motion and at rest across the supply chain. Furthermore, temperature sensitive supplies had to be maintained in cold chain conditions during storage and transportation to the investigator site.

Fisher Clinical Services provided these services and delivered all supplies on-time and in-full, achieving cost and performance efficiencies across a risk controlled supply chain to investigator sites.

The sponsor and Fisher Clinical Services worked closely throughout the duration of this trial to ensure a smooth supply chain and patient safety at all times.

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