Following European trends, Biosimilars are starting to grow in Brazil, dividing the market with reference biological products, with expired patents.
In Brazil, this new market segment is quite new and still has several vagueness, so we believe that for a better answer to the question above, here are some reflections:
1. Are Synthetic and Biosimilar Similar Products Different in Design? Biosimilars are biological products, which are made from cell lines distinct from the reference product, reaching the same asset. Because of this differentiation, Biosimilars are in fact new products, and therefore, unlike Similar Synthetic Products, in addition to many tests, Phase I and Phase III studies are required for their development and approval, which prove their effectiveness and safety. compared to the benchmark comparator, requiring greater investment in development by companies.
Even among Biosimilars there are simpler production active ingredientes such as Heparin, and other more complex ones, such as Monoclonal antibodies. The more complex ones are more difficult to produce and, therefore, require even greater investments by companies interested in operating in these segments.
2 - Is it possible to differentiate Biosimilars in the market? - As stated above, Biosimilars are new products in themselves; the robustness of the tests, Phase I and Phase III studies allow for differentiation, demonstrating quality, effectiveness and safety. The relevance of differentiation increases as the complexity of the active ingredient and the final indication of the product increases.
3 - Are the sales channels of Biosimilars differentiated? - The sales channel is mostly Hospital / Institutional. Products tend to have a higher added value and therefore there is usually a public or private buyer / payer. The price is an important factor to compete in this market; however, it must be considered that the investments in the development of Biosimilars are higher, and, therefore, the price elasticity is lower when compared to similar synthetic products. For distribution these products need cold chain, make logistics more expensive and complex.
4 – Is it important to interact with the prescribing doctors? It is extremely important that prescribing doctors know the Biosimilar and the studies that attest to the product's efficacy and safety, especially those who treat complex diseases, such as Cancer, Rare Diseases, Autoimmune Diseases, etc. The doctor needs to be confident in the therapy being delivered to his patient, even in situations where the purchase of the product was carried out by bidding.
5 - What is the patient’s role in this new market? Many biosimilars are developed for therapy of serious diseases, where patients and their families are highly involved with the treatment. A change of product reference to the Biosimilar can make the patient insecure, so the information is essential. Patient Associations should also be considered for preparation and education of patients on new therapies.
6 - Is it possible to exchange a Biosimilar for another with the same active ingredient? This exchange, called interchangeability is possible, but there must be well-defined rules to not compromise the effectiveness and safety of the treatment. In Brazil, this is still a topic under discussion within the Ministry of Health, but in Europe, in countries where there is widespread use of Biosimilars, it is defined that interchangeability can occur only after 6 months of treatment, with efficiency and safety follow-up, through well-structured pharmacovigilance programs.
Finally, we know that the companies that will operate in this market will carry out their projections and, within their vocations, will make their investment choices; however, it is important to emphasize that this is a new market segment and that perhaps it needs new Marketing and Sales Strategies to guarantee the competitiveness and success.