In Conversation with Aiswariya Chidambaram, on future of Biosimilars

Tuesday February 21, 2023 at 1:08 am

How has the market changed over the last few years for biosimilars in India?

The Indian biosimilar market has seen significant growth over the last five years, and it is expected to continue to grow in the coming years, primarily driven by government support, regulatory developments, increased awareness and access. According to a report by Research and Markets, the Indian biosimilar market is projected to reach $21.2 billion by 2025, growing at a CAGR of 12.8% from 2020 to 2025.

The Indian government has been actively promoting the development and manufacturing of biosimilars to increase access to affordable healthcare. The Department of Biotechnology and the Indian Council of Medical Research have been proactive in funding and extending support for biosimilar research and development. The Central Drugs Standard Control Organization (CDSCO) has issued guidelines for the development and approval of biosimilars, which are aligned with international guidelines. This has provided greater clarity and consistency in the regulatory process.

It is interesting to note that the Indian biosimilar market has witnessed the entry of several new players, including Biocon, Dr. Reddy’s Laboratories, Intas Pharmaceuticals, Lupin, Torrent, Hetero Labs, Cipla, among others, who have either recently entered this space or increased their focus on biosimilars. Nevertheless, Indian companies have been proactive in forming partnerships and collaborations with international pharmaceutical companies not just to manufacture and commercialize biosimilars, but also to diversity product segments and expand portfolios. Examples include Dr. Reddy’s acquisition of Biocodex’s biosimilars business in 2019, which included a portfolio of four biosimilar products in gastroenterology; Lupin’s acquisition of Symbiomix Therapeutics in 2017, which included a biosimilar product for bacterial vaginosis, to name a few.

Where do you think the role of researchers like you help in the biosimilar propagation

Analysts and consultants play a significant role in the propagation of biosimilars in several ways including but not limited to:

• Market Research & Analysis: Conduct in-depth market research and analysis on the biosimilar market to identify market trends, growth opportunities, and potential challenges. This information can be used to develop strategic plans and business models that can help biosimilar manufacturers to penetrate new markets and expand their reach.
• Regulatory affairs: Provide guidance and support to biosimilar manufacturers in navigating the complex development and approval process for biosimilars, including understanding, and complying with the relevant guidelines and evolving regulatory landscape.
• Market access and pricing strategies: Identify pricing strategies that balance cost-effectiveness with profitability and develop strategies to overcome barriers to entry in specific markets, thereby maximizing product uptake and market share.
• Competitive Intelligence: Enable biosimilar manufacturers to identify their competitors, understand their strengths and weaknesses, and develop strategies that differentiate their products and services from those of their competitors.

Can you touch upon on the role of Indian government in biosimilar expansion in India?

The Indian government has been actively promoting the expansion of biosimilars in India, recognizing the potential of these drugs to improve access to affordable healthcare. Following are some ways in which the Indian government has been supporting the expansion of biosimilars:

• Policy support: The Indian government has implemented policies and initiatives to promote the development, manufacturing, and use of biosimilars. These include the National Biotechnology Development Strategy, the National Health Policy, and the Make in India campaign, which encourages domestic manufacturing of pharmaceuticals, including biosimilars.
• Financial support: Provides financial support to biosimilar manufacturers in the form of research grants, subsidies, and tax incentives. For example, the Department of Biotechnology and the Biotechnology Industry Research Assistance Council provide funding and support for biosimilar research and development.
• Regulatory support: Established a regulatory framework for biosimilars that is aligned with international guidelines. The Central Drugs Standard Control Organization (CDSCO) has issued guidelines for the development and approval of biosimilars, which provide clarity and consistency in the regulatory process.
• Market access support: The Indian government is working to improve market access for biosimilars by promoting the use of these drugs in the public healthcare system. The government has launched initiatives such as the Pradhan Mantri Jan Arogya Yojana, which aims to provide health insurance coverage to economically vulnerable families, including coverage for biosimilars.
• Partnerships and collaborations: Fostering partnerships and collaborations between Indian and foreign companies to develop and manufacture biosimilars. These partnerships can help to improve the quality and affordability of biosimilars, as well as increase their availability in India and other countries.

Do you see any impact of covid pandemic in this field?

The COVID-19 pandemic has had a mixed impact on the biosimilar industry. On the one hand, the pandemic has highlighted the importance of biosimilars in improving access to affordable healthcare, particularly in the treatment of COVID-19-related illnesses, such as anti-inflammatory drugs and blood thinners. On the other hand, the pandemic has also led to disruptions in the supply chain, resulting in shortages/ delayed availability of biosimilars, reduced demand for certain biosimilars (non COVID19-related), and delays in clinical trials and regulatory approvals. Nevertheless, the most important lesson learned from the pandemic is the increased emphasis on local manufacturing of pharmaceuticals, including biosimilars, in order to reduce dependence on foreign suppliers and ensure greater supply chain resilience

What are the key challenges that you see?

The Indian biosimilar market faces several key challenges, including:

• Limited awareness and acceptance: Despite the potential benefits of biosimilars, many healthcare providers and patients in India remain unaware of these drugs or are hesitant to use them. This limited awareness and acceptance can lead to slower adoption of biosimilars and lower market penetration.
• Quality and consistency: Biosimilars are required to be highly similar to the reference biologic product, but the quality and consistency of biosimilars can be difficult to maintain, particularly with complex biologic products. Ensuring consistent quality and efficacy is critical for the long-term success of the biosimilar market.
• Intellectual property and legal challenges: The biosimilar market in India is heavily influenced by intellectual property and legal considerations, including issues related to patent protection, regulatory exclusivity, and data exclusivity. These legal challenges can create barriers to market entry for biosimilar manufacturers.
• Price competition: The Indian pharmaceutical market is highly price-sensitive, and biosimilars are often expected to be priced lower than the reference biologics. This price competition can limit the profitability of biosimilar manufacturers and create challenges in ensuring sustainable growth.
• Regulatory challenges: Although the regulatory framework for biosimilars in India is well-established, there are still challenges related to the approval process and regulatory requirements. These challenges can lead to delays in market entry and limit the availability of certain biosimilars.
• Manufacturing challenges: The complex nature of biologics can make manufacturing biosimilars more challenging than manufacturing small molecule drugs. Ensuring that biosimilars are produced at a consistent quality and scale can be difficult and require significant investments in manufacturing capacity.

Where do you see the Indian biosimilar market in next 5 years?

The Indian biosimilar market is poised for significant growth in the next five years, propelled by a range of factors, including the increasing demand for biologic drugs, the growing acceptance of biosimilars, and supportive government policies. As biosimilars gain greater acceptance and awareness among healthcare providers and patients, adoption is expected to increase significantly, driving growth. With biopharmaceutical manufacturers continuing to invest in research and development, the number and variety of biosimilar products available in the market are expected to increase, expanding treatment options.

The Indian government is pushing for greater local manufacturing of pharmaceuticals, including biosimilars, to reduce dependence on imports and increase supply chain resilience. With the growth of the Indian biosimilar market, competition among biosimilar manufacturers is likely to increase, putting pressure on pricing and profitability. This in turn is expected to make the biosimilar landscape more competitive with manufacturers increasingly focusing on collaboration and partnerships to drive growth and leverage complementary strengths.

Thus, The Indian regulatory framework for biosimilars is expected to continue to evolve in the next five years, with a focus on streamlining the approval process and ensuring consistent quality and efficacy