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Follow-on Biologics: patent issues in Brazil

Recent news on the forthcoming expiry date of patents related to important biodrugs in Brazil has aroused the medical-scientific community´s attention on follow-on biologics.
Brazilian doctors are worried about the safety and efficacy of biosimilars and have questioned the criteria for “market approval” determined by ANVISA (the National Health Authority), based on quite cursory clinical studies.

The government, on the opposite side of the discussion, is interested in speeding up the regulatory path for those biosimilars in order to reduce investments in the purchase of biodrugs to be distributed by the SUS (the Public Health System).

Biodrugs, although representing only 1-2% of the medicines supplied in Brazil, amount to 34-40% of the corresponding Ministry of Health´s budget.

ANVISA´s Resolution RDC 55 talks about “biological drugs” and “new biological drugs”. Biosimilars would be classified as “biological drugs”. Still according to that Resolution, “biological drugs” can follow two paths for market approval purposes: the comparability path and the individuality path. In both options some aspects of the clinical studies are simplified.

Regarding patents, three important aspects must be analyzed, besides the obvious need for the object of the reference drug’s patent to be in public domain.

– the absence of regulatory extensions such as “data exclusivity” in Brazil for pharmaceutical drugs for human use. Therefore, a priori, as soon as the patent expires, the biosimilar’s market approval may be requested;
– the complexity of the process for producing biodrugs. The reproducibility of biodrugs is so difficult that it might be even possible to challenge the sufficient description of some granted patents on reference drugs. The pharmaceutical industry of biosimilars needs, therefore, to rely on reverse engineering;
– the economic aspect. Not only the production costs of biosimilars are much higher than those of generic drugs (with small molecules), but also the expenses involved in the market approval process, due to the need of clinical trials, reduce the profits on the sale of those drugs.

Therefore, the “biological drugs” industries in Brazil will tend to invest on “biobetters” which include innovation that can be patentable and may increase profits in the sector.

Carmen Sánchez-Puelles