Over the last five years, biosimilars have progressively gained traction. Global sales are expected to more than double to $15 billion by the early 2020s, with emerging markets accounting for $5 billion to $8 billion. Multinational organizations seeking their entrance into emerging markets of the world focus on the biologic-treatment rates of countries and are more eager to enter a market full of opportunities for them with a low biologic-treatment rate. As in china different segments of patients having cancer are treated with biologics anywhere ranging from 10% to 20-25% when compared to the US ranging from 55% to 70% biologic usage for the same segments. This poses as the potential market for biosimilar development organizations, but along with the opportunities comes the challenges and the difference in the scenarios of regional regulatory guidelines for the same. To prove the similarity of the product, the proposed biosimilar must be thoroughly evaluated, including a side-by-side comparison with the reference product. The developer of the reference product must conduct substantial preclinical investigations and significant clinical trials in all indications for which approval is sought during the development process. Therefore, there is a significant evolution in the regulations related to the development of biosimilars in global emerging markets. Let’s take a glance at the situations, challenges, complexities, etc. of the same.
Difference in Regulations to Biosimilar Development in Emerging Markets
When talking about emerging markets such as Malaysia, the Middle East, Brazil, etc. there is a significant change in the regulations to be followed by biosimilar development organizations. They need to follow different scenarios related to the regulations, market situation, pricing models, affordability, etc. And these are pretty much the most important factors that need to be addressed when talking about biosimilar development. So, assessing the regulations in these emerging markets is necessary for every organization. Companies must select markets with a growing regulatory framework and policy incentives that promote biosimilars in order to gain access and develop a sustainable market share. Most emerging markets that have one have modelled it after the World Health Organization (WHO) or the European Medicines Agency (EMA). In fact, Brazil has a pretty solid regulatory foundation that provides acceleration in the approval of biosimilar development establishments. But in many different markets, the market scenarios aren’t quite attractive as they happen to support local manufacturing and offer quite a low resistance to investors. Such conditions result in significantly low returns on the investments of any foreign organizations that plan to enter the markets. So, market stability and the establishment of a solid regulatory framework is the prime requirement of any development organization and requires close attention in the coming time. In emerging markets, the ability to maintain profitability is another challenge for the upcoming biosimilar developers. It is due to the low reimbursement rates and the limited ability of the patients to pay for the same, that acts as a barrier for the harmonized pricing models of most of the investors. It is one factor that bothers even the local manufacturers and makes them develop such a competitive pricing model that they’ll be making a profit out of it. When you compete in emerging markets, you’re competing in a price-driven market. In addition to implementing novel pricing methods to address affordability, biosimilar companies must aim to differentiate themselves in order to maintain profitability and encourage market switching to lower-cost alternatives. Therefore, companies can capitalize on the strategies that have already proven to be beneficial to them in the developed markets. Adopting the same strategies in the emerging markets can provide them with a different business model when compared to the local manufacturers and can also let them capitalize on their investments while entering the emerging markets. These strategies can involve the implementation of supply chain control to ensure reliability and flexibility, the introduction of support programs for the professionals, using examples from the developed markets, etc.
Challenges & Complexities in biosimilar regulation guidelines
A carefully structured channel strategy with clear goals is required to maximize biosimilar uptake in emerging areas. A corporation could, for example, target large hospitals in urban areas with higher patient flows for specialist care, clinicians open to new treatment methods and patient segments that can afford complex treatments. The second layer of targeting could include selecting places with stronger biosimilar penetration in the past and tailoring legislative incentives like prescription quotas or profit-sharing. This remains a challenge as in diverse markets and geographies, it is quite difficult for organizations to find the appropriate channel and target the audience with the same. Despite the fact that tendering and contracting in developing markets is primarily about pricing, corporations frequently have room to modify the selection criteria. And in emerging markets, the selection criteria are mainly based on the regional regulations and the requirements of the organization in the same. For example, in a big market with a developed regulatory framework, organizations can focus on the factors that increase their reach in the region, but for an emerging market they, need to follow a different approach that can address the requirements for the establishment of their investment as well as creating a framework that initially delivers more value to the market. So, this is another challenge for organizations to focus on value delivery rather than diversification of their establishment.
Biosimilars have a lot of potential in emerging markets with low biologic treatment rates and price obstacles that prevent patients from getting expensive, new therapies. Pharma businesses should join nations with favorable legal frameworks, use creative pricing strategies, differentiate themselves to build long-term market share and collaborate with local partners to reap the benefits. And this is the key for biosimilar development organizations to enter emerging markets.