BOGOTA, Colombia – With an investment of $5.5 million in Costa Rica, Swiss major Roche AG is expanding its operations in Central America and the Caribbean after almost doubling its business in a few years.

"Our business has grown double-digit numbers in the region over the last years, requiring the amplification of our facilities," Stephan Julsing, general manager of Roche in Central America and the Caribbean, told BioWorld Today. "This amplification was especially needed for the distribution center, but also for the administrative, commercial and medical departments.

"After evaluating several alternatives, Roche decided to invest $5.5 million in a new building in Costa Rica," he added. "The new center will allow us to strengthen the platform of the distribution services that we provide from Costa Rica to 23 countries of Central America and Caribbean."

Roche´s presence in Costa Rica, a country with a population of about 5 million, dates back to 1973, but the company's growth in the region in the last couple of years required more space and facilities. The latest investment aims to boost the company's capacity to store and deliver biotech products in the region.

The new 5,000-square-meter building will be about one-fifth larger than the company's previous facility.

"In terms of square meters we are growing 44 percent on space dedicated to biotech products," said Julsing. "However, due to a better distribution of the warehouse space and the use of new equipment, like racks and modern forklifts, we are able to increase the number of storage positions from 190 to 420. He explained that, with the investment, the company also duplicated the space capacity for cold chain products.

Roche´s move also is in line with the company's latest financial results and its perspectives for the Central American and Caribbean markets.

"In the last seven years we doubled our turnover to $160 million. According to our market knowledge, however, still more than 60 percent of the patients we serve do not have access to our biotechnological medicines or other standards of care in our region," said Julsing. "Theoretically we could hence more than double again, only with our existing biotech portfolio," he said. "In addition, we have new innovative therapies in our pipeline that will reach the market in the coming years, like treatments for multiple sclerosis and for severe asthma."

POLITICAL AGENDA JUST AS IMPORTANT

To achieve the goal of doubling the market, the company has set a political agenda to help to open and strengthen the biotech market in the region.

"Our growth depends largely on the political stability in our countries, as well as the public investments in health care and medicines specifically. Hence our political agenda is as important as our technological agenda," said Julsing.

However, Julsing recognized that Costa Rica´s political stability was one of the main reasons for Roche to make the investment in the Latin American country.

"Roche decided to keep and strengthen its regional head office in Costa Rica for a number of reasons: the political stability, the relatively strong economy, the health care infrastructure, quality of education and human talent, relatively high safety level as well as strong legal system," he said.

Julsing also said that Costa Rica, along with Panama, Guatemala and Cuba, have specific regulations in place for the registration of biotech products. However, he warned of a lack of specific regulations in the other countries of the region.

"The rest of the countries of the region do not have specific regulations for biotech products, but are still registering these drugs with the same requirements of pharmaceutical products of chemical origin," said Julsing. "This is particularly critical for biosimilars, because the generic pathway of evaluation for the approval of these drugs does not guarantee their quality, safety and efficacy."

The general manager of Roche in Central America and the Caribbean also pointed out that the main regulatory barriers that the company faces in the region have to do with lack of capacity of governments to handle the regulatory issues, as well as lengthy processes to register new products.

"Health authorities of the region are facing constraints related to lack of resources and a high turnover of technical personnel. This is especially the case when a new government is formed after presidential elections," said Julsing. "In some countries the registration timelines for innovative products are very long, regardless of the fact that these drugs have already been approved by countries with high and stringent regulatory standards like [the] U.S. FDA or EMA."

Julsing warned that the regulations in the region do not include expedited evaluation pathways for innovative therapies for unmet medical needs, which in the end, he said, affects the patients´ access.

Thus, Julsing suggested that Central American and Caribbean countries lacking specific regulations should urgently adopt international guidelines to regulate the sector.

"In the near future we would like to see regulations in place for the registration of biotechnological products, including biosimilars, in the entire region," he said. "Considering that in most countries formulating new regulations may take a long time, our recommendation for these countries is to completely adopt the guidelines already available from the World Health Organization, or from stringent regulatory authorities like the U.S. FDA, EMA and Health Canada. Following these guidelines would guarantee that only products that have proven quality, safety and efficacy reach the patients."