The Regulation of Biosimilars in Argentina
By Moeller IP Advisors
Research and production costs for developing pharmaceuticals are extremely high, especially for biological drugs. Biopharmaceutical companies can expect to spend up to US$ 1.3 billion for developing and testing a single drug, and the costs are constantly increasing.
The expiration of the exclusive rights conferred by patents causes a further profit loss – which has been estimated around US$ 70 billion between 2010 and 2024.
Pharmaceutical companies have developed a way to extend the profitability of patented drugs: they test molecules whose patents are about to expire or have expired and develop biosimilar drugs at a much lower price than the original pharmaceutical.
Biosimilars share an identical protein sequence and common amino acid sequence with the originals and have similar characteristics, efficacy and safety. They can be developed and tested quickly at a fraction of the cost, they need around 6 to 9 years of clinical trials. In some cases, biosimilars can also be patented.
Argentina’s biopharmaceutical industry
In the 80’s, Argentina was a leading initiator in South America for biotechnological research. According to a report of the World Bank, Argentina’s investment in R&D of new pharmaceuticals is still among the highest in the region, although it is much lower than the average investment of other developed countries around the world.
Public funds to support the development of the biopharmaceutical research industry exist, but they are not significant and the median expenditure on R&D for each company is relatively low – around US$ 250,000 per year in 2012. In 2007, Argentina adopted a National Biotechnology Plan. The Plan, however, was never properly implemented.
Exports of pharmaceuticals reached US$ 850 million in 2014: among this, US$ 55 million came from APIs and biopharmaceutical products. The main developers of biopharmaceuticals in the country are Instituto Malbrán, Elea, Instituto Massone, Beta, and Biosidus.
In 2013, Laboratorio Elea produced Novex, a biosimilar of the oncologic drug Rituximab: so far, this has been the only biosimilar produced by an Argentine company, which has received marketing approval in the country.
Regulation of the sector
In Argentina, the authority responsible for approving new pharmaceuticals is the National Drugs, Food and Medical Technology Administration (ANMAT).
ANMAT has established several regulations concerning biosimilars. A pharmaceutical is considered biosimilar if it is derived from an original product, called comparator, with which it shares common features.
In particular, ANMAT Regulation 7075/11 establishes the requirements for the registration of biological pharmaceuticals, while the ANMAT Regulation 7729/11 sets the prerequisites for registering biological drugs whose composition and therapeutic use shares a common background with other biological drugs previously authorized by ANMAT.
Finally, ANMAT Regulation 3397/12 approves the specific requirements for the submission of applications for the authorization of biological drugs and monoclonal antibodies obtained by recombinant DNA methodologies.
Applicants that want to register biosimilars at the ANMAT must provide studies demonstrating that the biosimilar share common features with the comparator in terms of the identity, potency and purity of the product.
The applicant should also provide clinical trials, studies (‘in vivo’) and reports on the relationships between possible adverse effects and molecular characteristics of the biosimilar.