Novartis is looking to consolidate its position within the Brazilian biosimilars R&D market through a Sandoz clinical trial for developing oncology biosimilars treatments in the country.
IHS Life Sciences perspective | |
Significance | Sandoz's intention to consolidate its presence in Brazil is strategic as it is aimed at expanding its presence in the country as well as strengthening its pipeline. |
Implications | This is the first biosimilar trial based in Brazil for Sandoz and its success could translate into faster penetration for biosimilars in the market. |
Outlook | Emerging markets such as Brazil and Mexico are candidates for becoming competitive testing grounds in the near and medium term for biosimilar products. |
Novartis (Switzerland) is seeking to consolidate its position in the Brazilian biosimilars market, reports PharmaBIZ. According to the source, Sandoz, the generic and biosimilars arm of the company, has been developing the first clinical trial for developing monoclonal antibodies (mAbs) as an oncology biosimilar treatment in Brazil.
The Brazilian Institute for Cancer Control (IBCC) is partnering with Sandoz for this clinical trial. According to Felipe Cruz, who is responsible for clinical research at IBCC, the biosimilar trial is a new approach to tackling cancer in Brazil, with biosimilars viewed as the best way to access advanced drugs in developing countries.
Brazil's biosimilars R&D landscape
During the last two years, the main markets in the Latin America region have tried to incorporate biosimilars regulation with different approaches regarding the requirements for biosimilars clinical trials. In the particular case of Brazil, it has adopted the comparative pathway which means the need for pharmacodynamic and pharmacokinetic studies, and Phase III trials recognised by the Brazilian Health Surveillance Agency (Anvisa; see Brazil: 24 October 2011: Anvisa Publishes Guidelines for Biosimilars).
After the promulgation of Anvisa guidelines for biosimilars, several biosimilars have entered the Brazilian market, including Sandoz's biosimilar version of human growth hormone Omnitrope (somatropin), which entered the market in May (see Brazil: 31 May 2011: Sandoz to Introduce Biologic Omnitrope Onto Brazilian Market).
Prior to the passing of guidelines for the abbreviated approval of biosimilars, Brazil already had a number of biosimilar products on the market, but trust in those by the general public and prescribing physicians may have been lower given the absence of clear regulations for their approval. Additionally, Brazil's government has been implementing technology-transfer agreements and public-private Productive Development Partnerships in order to strike a balance between R&D investment done by international companies and Productive Development Partnerships that enable local pharmaceutical companies to produce innovative products(see Brazil: 25 June 2013: Brazil to expand local production of biologic drugs with 14 new products).
Sandoz's intention to consolidate its presence in Brazil is strategic as it is aimed at expanding the company's presence in the country as well as strengthening its pipeline. During the last year, Sandoz has been focusing on consolidating itself as the main producer of high-technology drugs, such as biosimilars and injectable products, especially cancer treatments. Sandoz has three products in the pipeline in Brazil with another 8–10 molecules being developed (see Brazil - Switzerland: 5 February 2013: Novartis to reinvigorate marketing strategy in Brazil and Brazil - Switzerland: 25 March 2013: Sandoz to consolidate presence in Brazil).
Outlook and implications
Taking into account that biologic cancer drugs tend to be more expensive than small-chemical drugs, developing copies of biologics would help make those drugs much more affordable to the Brazilian population. The production of biosimilar drugs will also help to boost the domestic pharmaceutical market in size and revenue while increasing exports.
The biosimilars market in Brazil is currently valued at more than USD1.8 billion, with a forecast of reaching double growth by 2016. Emerging markets such as Brazil and Mexico are candidates to becoming competitive testing grounds in the near and medium term for biosimilar products. Getting rapidly into emerging markets could have several advantages for pharmaceutical companies, such as saving costs and early consolidation in booming economics. Western companies such as Sandoz can also consolidate their presence by providing an alternative to local companies – which were among the first to launch biosimilars before approval regulations were in place. This is especially true in Brazil, where the local near-term economic momentum creates a significant opportunity as affordability increases in response to middle-class growth.