Mumbai: The Confederation of Indian Industry (CII) & Sathguru Management Consultants(SMC) released a position paper on Indian Biosimilars Industry – “Indian Biosimilars Industry: Roadmap to Actualize Global Leadership” at the 2nd National Biotechnology Conclave 2018 – Driving Inclusive Growth for Indian Bio-economy Vision- 2025 organised by CII in Delhi.
In the recent press release, CII and SMC mentioned about an active engagement in Indian industry with about 70 approved biosimilars and an urgent need to expand markets & de-clog RoW market access to actualize potential for global leadership.
The press release states that biosimilars present a very attractive opportunity for Indian pharma companies going beyond small molecule generics ridden with intense competition and price pressures. Based on analysis of currently approved biologic drugs and global pipeline, in the most optimistic scenario, we estimate that the global biosimilar market will be worth of $240 Billion and Indian biosimilars market will be worth of $40 billion by 2030. Growth is being driven by increasing market maturity in Europe, more recent forthcoming environment for regulatory approvals in the US and high unmet clinical need across RoW markets.
With a record number of domestic approvals, active engagement in semi-regulated markets and growing footprint in regulated markets, the Indian biosimilar industry is poised at the cusp of growth. There are more than 70 biosimilars approved in the country today. The revised Indian guidelines released in 2016 have not only resulted in a rigorous framework for approvals in India but have also paved the way for leaner bridging effort to enter global markets. At this juncture, it is imperative to nurture the vibrant industry landscape and support the industry in value realization. Major challenges to combat to secure a sustainable future for Indian-made biosimilars and key recommendations are as follows:
Firstly, expanding markets in the domestic landscape: Biosimilars as a means to overcoming affordability barriers is a promise that is a promise that is yet to be translated to reality in several countries including India. Though the substantial level of price erosion has been breached, overall market size is currently unattractive as volume penetration remains significantly low. For instance, one of the more mature assets in India, Trastuzumab biosimilar had overall sales of about Rs. 286 crores in 2017 translating to less than 10% penetration when assessed on the basis of overall clinical need. Price control has had an insignificant impact on expanding access as the overall cost of care in indications such as oncology still remains out of reach for the majority of the population. Hence, is it is important to consider other models of aggregated and negotiated to buy for public health so that blanket price control can be avoided. It is critical that affordable biologics are included in national coverage programs to expand access, especially at a time when landmark public health programs such as Ayushman Bharat Pradhan Mantri Jan Arogya Yojna(PMJAY) are rolled out. Finally, as done in certain European countries with high success in biosimilars adoption, a multi-stakeholder approach has to be engaged to drive greater awareness, clinical adoption and market expansion.
Secondly, strengthening upstream technology backbone: Sustainable success in the segment will hinge on production economics, especially as prices erode and unit cost and enhanced CapEx recovery become critical. There is an urgent need to strengthen the industry’s backbone in upstream technology development, especially in areas such as high yielding clones and industry-academia platforms should be explored. For near-term impact, globally benchmarkable non-dilutive funding and fiscal incentives for technology acquisition should be considered.
Thirdly, paving the way for sustainable leadership in global markets: As regulated markets embrace biosimilars and move towards higher market maturity, it is optimal time for the industry to expand thrust on regulated markets, that will constitute the majority of the near-term global markets by value. However, given the significant level of binary risk per asset (clinical development investments of about $100 to $150 million per asset), the key to defraying risk and expanding investment appetite will lie in more aggressively pursuing strategic partnerships with global as well as domestic counterparts. The Biocon-Mylan partnership is a great testimony to the strategic value of such partnerships and has resulted in Indian developed biosimilars being among the first wave of approved assets in regulated markets. For RoW markets, the WHO PQ presents great promise as a mechanism that can provide aggregated access to multiple markets that are relatively less mature. India should encourage fast-tracking of the WHO PQ pilot while pursuing regulatory reciprocity in select markets until such aggregated possibility is a tangible reality.
Finally, as done through bodies such as PHARMEXIL in small molecule drugs, a multi-stakeholder approach to enhance global reputation and support global market access will greatly accelerate market expansion in the fragmented RoW markets.