On December 16, 2013, Columbia’s National Institute of Food and Drug Monitoring (INVIMA) announced the approval of Remsima (infliximab) for the indications of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.  Remsima is the first “similar” biotherapeutic product to be approved in Columbia and was developed by Celltrion in collaboration with Hospira.  To learn more, click here.

According to an article published on January 14, 2014 in Brazil Pharma News, Sindusfarma, (the Pharmaceutical Products Industry Union in the State of San Paulo) expects the sales of pharmaceutical drugs in Brazil to continue to be strong in 2014; however, profit margins are expected to decrease.  Specifically, the article notes that the expectation in 2014 is for industry growth to be around approximately 13% with revenues of approximately 24 billion (US dollars).  The highest growth is expected in the generic drug market.

In Brazil, “similar medicines” (drugs having a trade or brand name) will be afforded the same status as generic drugs (drugs having only the generic name of the active ingredient). In other words, pharmacists in Brazil will be allowed to substitute a branded product with a similar drug. Given this new status, the price of similar drugs will be required to be priced 35% lower than the referenced products.  To learn more, click here. 

An interesting article in the Guardian reports that several drug companies in South Africa have been accused of participating in a well-funded campaign to delay the introduction of changes to the patent law that would enable patents on new medicines to be bypassed in the interest of public health.  The trade body Innovative Pharmaceutical Industry Association South Africa (IPASA) was coordinating the campaign. IPASA reports that it is no longer going ahead with the campaign although it believes that it was legitimate for drug companies to promote their views in this manner.  To learn more, click here.