“The need for biosimilars is acute in emerging markets”

Kate Kuhrt
Senior Director, Proposition, Generics and Biotech, Thomson Reuters
Dr David Dunn, Practice Consultant in the Life Sciences and Professional Services Group, Thomson Reuters in an interview with Mahesh Kallayil shares strategies for Biosimilars in the Regulated and Emerging Markets.

How has bio-similar industry transformed in the last few decades?
Huge change in all aspects from the establishment of regulatory paths, development of know-how and functional capability in the manufacture of biosimilars to a growing awareness on the part of stakeholders such as physicians, legislators, payers and patients.

What are some of the opportunities that are still under-utilized in this field?
The need for biosimilars is acute in emerging markets such as India, China and Latin America. The cost of biologics is a challenge for payers in Europe and the US, but completely out of reach in these regions. The Indian biosimilars industry has met this challenge for it’s own patients. Going global is an opportunity for the Indian industry that has demonstrated capability.

What are the challenges in regulation that you need to be addressed?
The biggest challenge is the diversity in regulatory paths in all regions of the world. Even the definition of the term “biosimarity” differs across regions. TO go global requires a strong understanding of the regulatory requirements in different countries and the ability to assemble a successful plan to carry a product through the approval process.

What are your views on payers driving the utilization of bio-similars in Europe?
Physisicians must gain understanding of biosimilar products to the point of confidence that these drugs will be safe and effective for their patients. Once prescribers are anxious to prescribe biosimilars, payers will be open to being more aggressive in demanding that biosimilars be utilized.

As Indian pharmaceutical industry increases its focus on bio-similars, what challenges you see in biologics outsourcing?
The challenges are and will remain meeting quality standards on a consistent basis. The other challenge will be to identify and select the right portfolio and for partnerships to enable a global strategy.

What is the standing of Indian bio-similar industry in international market?
There is a strong motivation for Indian biosimilars providers to translate their know-how and capability to a global strategy.