Biosimilars: the obvious alternative or a simmering source of future friction?

/ / Legal x-rays

In the few past years, biosimilars have found their place in the pharmaceutical market. Having already played a significant role in European life, they continue to win market share in the EU and the international market. The constantly increasing state expenditure favor their growth as they appear to assist in the sustainability of the global health system. States can indeed insure more patients and simultaneously save costs. However, the success of biosimilars depends on the rules and legislation of every individual market.

Biosimilars constitute an alternative choice to reference biological products and follow the same market mechanism. They enter the market after the expiration of the patent of the original product and provided that they can demonstrate the same quality, efficacy and safety as their reference products. In order, however, not to confuse ourselves, we should mention that biosimilars and generic products do not fall in the same category: generics constitute an exact copy of the original.

The World Health Organization defines biosimilar as “a bio therapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference bio therapeutic product.” Additionally, the US Food and Drug Administration (FDA) gives a similar definition: “a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product”. Only minor differences in clinically inactive components are allowable in biosimilar products.

In the EU level, the European Medicines Agency (EMA) , using agreed guidelines between Member States, defines biosimilar medicine as a biological medicine that is similar to another biological medicine that has already been authorized for use. According to the EMA’s rules, a biosimilar medicinal product and its reference medicinal product are expected to have the same safety and efficacy profile and are generally used to treat the same conditions.

The European Medicines Agency is the qualified body for the evaluation of biosimilar products in the European Union following the EU centralized procedure. The evaluation takes place always after the lapse of the period of data exclusivity of the original which lasts from 8 to 11 years. However, the final market authorization is granted by the European Commission (Directive 2001/83/EC, as amended by Directive 2003/63/EC and Directive 2004/27/EC, Regulation  2014/726).

It is noted that the entire legal framework set out by the EMA according to the 2005 and 2015 European guidelines regarding the development and the evaluation of biosimilar products, constitutes a model system of binding rules followed by other countries incorporating it in their own legal systems, in part, or unchanged.

For instance, countries like Australia, Canada, Japan, Korea and Switzerland have adopted a great portion of these guidelines. Furthermore, the European Union occupies the first place in biosimilar authorizations; within the last ten years, 22 biosimilar products have been approved and distributed in the EU market, while in the US, the number of authorized biosimilars is only 2. However, in the following years, a rapid increase in biosimilar products within the EU market and the rest of the world is expected. The reasons? The increased need for biologic products and the awaited patent expiration of many innovative biological drugs.

Today’s biotech companies have a strong motivation to develop biosimilar products in order to gain a bigger share of the biologic product market. On biosimilar products and despite the high investment required, there is a lower financial risk compared to the innovative products, since the final result is a copy close to the reference product. However, the innovative companies often find beneficial to stall the development of new biosimilars, relying on intellectual property issues. A good related legal policy is asking biosimilar producers not to use the name of the reference products on their label: we should recall that contrary to generics, biosimilars are not identical but similar to the prototypes.

The debate over the non-proprietary name is intense both in the US, where a recent solution foresees using four random name suffixes for biosimilar products and the European Union, where the Member States agreed that the non-proprietary name will be the same for all, biological and biosimilars alike. However, the innovative companies continue to mention security issues and dangers of careless substitution of products which are not interchangeable.

Interchangeability becomes thereby an issue raising many discussions. On one side, the innovative companies threaten to bring before the court legal cases approving interchangeability with biosimilars. In the EU, the decision on interchangeability must be taken by the Member States themselves. Therefore, we can find different approaches depending on the social and economic rationale of each governing authority. Additionally, Member States are entrusted by law with establishing a list of interchangeable products. Under this manner, the EU has become a region where one can find countries which have already introduced prohibitive laws for automatic substitution, like Spain and Sweden, countries based on guidelines against automatic substitution like Greece, Italy and Germany and countries with no rules at all, like Portugal, the Czech Republic and Lithuania. And what lies ahead? Just recently, France permitted a restricted form of automatic substitution. This could pave the way for other countries to act accordingly, in the near future.

Our law firm’s comment:

We expect that in the following years biosimilar products will thrive in the European and international market as a result of the need to use more biological drugs and the big number of patents which are expected to expire. It is also notable that biosimilars are granted their market authorization after rigorous controlling procedures and that no incidents of adverse effects have been reported until today. However, due to the fact that they are quite new at the consumer market, they should be monitored even after market authorization is provided, in order to ensure their safety.