Anvisa approves first monoclonal antibody (mab) biosimilar
April 27, 2015

The Brazilian food and drug agency (Anvisa) granted today (April 27) marketing authorization to Celltrion’s Remsina, the first approval granted for a biosimilar monoclonal antibody in Brazil, a copy of Janssen’s Remicade (infliximab). The approval followed the abbreviated pathway set forth on Anvisa’s Rule #55/2010, which does not use the terms “biosimilar” or “biogenerics”, but “new biologic product” for innovators and “biologic product” for copies.The purchase of drugs by the government raised from USD 1.2 billion in 2003 to approximately USD 6 billion in 2013. Biologic products represent 51% of the budget for healthcare in Brazil. In 2015, approximately USD 49 million were spent with Remicade (infliximab).Celltrion is a Korean company and it obtained the first marketing authorization for Remsina in Europe in 2013. The request for marketing approval was filed in 2012 in Brazil. Anvisa’s regulation for biologics, Rule #55/2010, establishes two pathways for abbreviated approval of copies of biological products:development by comparability (article 22, XXV) and individual development (article 22, XXVI).The individual development pathway requires the submission of full dossier data on development, manufacturing and quality, in addition to non-clinical studies and clinical studies performed with the product. The comparative pathway requires the submission of a comparative dossier containing non-clinical and clinical studies used to demonstrate comparability between the biological comparator product (reference) and the follow-on the biological product seeking approval.Remsina was approved under the development by comparability pathway. Article 18 of Rule #55/2010 provides that all therapeutic indications requested for marketing approval by comparability pathway must be documented in the clinical studies, and allows the extrapolation of data on safety and efficacy for additional therapeutic indications of biological products registered by comparability.Remsina’s approval has the same expiration date (thirty-six months) and the same therapeutic indications as Remicade: rheumatoid arthritis; ankylosing spondylitis; psoriatic arthritis; psoriasis; adult and pediatric Crohn’s Disease; fistulizing Crohn’s disease; adult and pediatric ulcerative colitis or retocolitis.Upcoming interchangeability challengesAnvisa issued a statement in 2007 informing that biologics are not per se interchangeable, but did not publish guidelines addressing interchangeability between biologic products.Brazilian government has a legal duty to distribute drugs for free for the population through the national healthcare program (SUS). Physicians working in public hospitals prescribe drugs using the Brazilian Common Denomination (DCB), which is similar to the INN. For instance, there are more than 4 different toxin botulin approved before Anvisa that are prescribed by the INN, despite the possible differences between them.Remsina may reach the Brazilian market shortly, and there are concerns regarding interchangeability with Remicade. The government buys medicines in public bids, where the lower price will prevail, without any consideration regarding interchangeability. In the current system for distribution of medicines in Brazil, a patient can receive either Remicade or Remsina. In this scenario, illegalities may lead to sanitary issues.Ministry of Health announced Anvisa’s new substitute CommissionerIn addition, it was published today in the Federal Register that Mr. Ivo Bucaresky, economist, is the new substitute Commissioner of Anvisa. Mr. Bucaresky joined Anvisa in July 2013. Before joining Anvisa he was in charge of CMED, the Brazilian price control board.