Commercialization is the next frontier for biosimilar developers. As more and more biosimilars are gaining regulatory approvals, the discussion on commercial aspects of the yet evolving market is gaining momentum.

Biosimilar commercialization will have its very specific attributes and nuances. Biosimilars are neither first- nor best- in class products, these are categorically “similar” products which are “me too” in terms of safety and efficacy. The innovators and big pharma players, used to product/brand marketing, will find it difficult to market a “copy-cat” product. The traditional generic companies will have a significant learning curve vis-à-vis stakeholder awareness / education, patient support and semi-branded pricing. The pure-play biosimilar developers and the new entrants to the biopharmaceutical industry will have the hardest time establishing corporate and product identities together.

Based on our observations and analysis of the biosimilar development and messages, we posit the following elements as prerequisites to any player´s go-to-market strategy:

1. Depth and breadth of scientific evidence: The evidence for clinical equivalence is the first core ingredient of any commercial strategy. Additionally, clinical evidence in all approved indications (of the reference biologic) will help in mitigating any doubts especially for the Physicians. The post approval, real world evidence studies will create a strong support for the study sponsor to claim the biosimilar market share. The clinical and non-clinical data should be effectively communicated to all the stakeholders including physicians, payers, and patients and policy makers
2. Economic analysis: The payers and health economists are looking at biosimilars as a tool to reduce healthcare costs. It is therefore in the developers’ interest to provide pharmacoeconomic data to create a cost-effectiveness argument of course, in favour of their own product(s) and/or portfolio
3. Differentiated ‘value’ to customers: Patient cost-benefit is, in our opinion, too narrow to be a sustainable driver of any player´s commercial strategy. Biosimilar developers will be required to augment their offerings with differentiated non-clinical benefits. Efforts towards patient compliance, improved delivery systems, patient-friendly packaging, patient support programs etc. will add value to the customers and generate the much-needed differentiation in a me-too-yet-its-complicated market dynamics
4. Tailored access models: Increased patient access is yet another aspect of biosimilars. The ability of the drug developer to tailor drug access models as per the need of the local market and available commercial channels will play a critical role in the biosimilar uptake.

The recipe for successful biosimilar commercialization is not known thus far. The current situation seems to be a little skewed towards the big innovator firms, who are relying primarily on the existing Brand Equity. Customer centric approaches and improved patient outcomes will help the smaller players to compete successfully in this rapidly evolving segment.