The registration of biosimilar medicines: lessons from Colombia’s experience

By German Velasquez

On 18 September 2014, the President of Colombia Juan Manuel Santos signed a decree defining the way and the standards that the country will require to register biosimilar medicines (products that replicate third parties’ biological products). With the decree to open competition for biotech medicines, Colombia has won a battle but not the war.

The presidential decree that will allow the entry of new products and laboratories to the closed world of biotech drugs was celebrated in Colombia   as a courageous decision against the power and pressure from the transnational pharmaceutical industry, owners of a big monopoly worldwide. The power of the transnational pharmaceutical lobby is so strong that they had succeeded to convince the Vice President of the United States, Joe Biden, to send a letter to prevent Colombia from taking this step. After the signature of the decree, it is foreseeable that bilateral and industry pressures will not cease and the battle will continue in other scenarios.

Ten or 15 years ago most of the drugs used worldwide were obtained through chemical synthesis. Today, biological drugs constitute a growing global market that may reach 6 billion USD in 2016. According to the Colombian Health Minister Alejandro Gaviria, last year biotech medicines accounted for 35 percent of the pharmaceutical market in Colombia, and the sector is growing rapidly. There are more and more new drugs for conditions such as arthritis, diabetes, cancer, hemophilia, multiple sclerosis, hepatitis and many rare diseases. These drugs account for a major portion of all reimbursed drugs under the Colombian Solidarity and Guarantee Fund (Fosyga). There has been a heated debate in Latin America and other countries about how to set regulatory standards to allow the reverse engineering of these drugs, known as ‘biosimilars’ or ‘biogenerics’ or ‘biocomparables’ in order to lower their costs for patients and health security systems.

As most of these biotech medicines may have patent exclusivity for 20 years, companies have been able to exercise a monopoly that enables them to set very high prices. This situation in some cases can put at risk the economic viability of the health system. For several years Colombia and other countries have discussed the way for national companies and laboratories to manufacture similar or equivalent drugs to achieve lower prices, and thereby facilitate access for people with low resources. The same battle has taken place for decades between the producers of ‘original’ and reverse engineered drugs known as ‘generics’.

It is estimated that by 2020 half of biological patented medicines, which generate multimillion profits for the transnational pharmaceutical companies, will be out of patent protection. Some of these patents have already expired, but it is not clear whether they can be quickly reverse engineered.

The decree signed by the President of Colombia Juan Manuel Santos on 18 September is an important step forward to clarify this situation. The decree defines the way and the standards that the country will require to register biosimilar medicines. The Colombian government has chosen to favor   health needs and refused to create the technical barriers that multinational companies wanted to generate through marketing approval regulations to extend their monopolies.

The Decree

The original draft of the Decree introduced an ‘abbreviated route’ or ‘fast track route’ for the registration of biosimilars. Ultimately, the President decided to complement this mechanism with the concept of “comparability”, a clarification that substantially improved the decree. In fact, the route established by the Decree for registration of biosimilars is not abbreviated as it requires the strict compliance with all health requirements, tests or clinical trials necessary to obtain the authorization for a new drug to enter in the market, as is required in most countries. However, the decree avoids to extend the process, creating unnecessary delay through marketing approval regulations, as the transnational pharmaceutical companies wanted. As a result, the entry to market of biosimilars will not be delayed unnecessarily. As stated by President Santos, “the decree is not putting at risk the health of the Colombian citizens.”

The core of the debate about the possibility and ways to reverse engineer biological products is: are biotech products completely different from the products obtained by chemical synthesis for marketing approval purposes ? Is it possible to get a biotech ‘similar’ or ‘generic’ product? In the area of biological products it is evident that it is not possible to speak of “identical” products, because the use of biological materials do not permit to get perfect copies of a given product. What is needed, and was understood by the Colombian Ministry of Health, is to have an equivalent therapeutic effect with products that are safe, effective and of good quality.

This debate will increasingly occupy health agendas in the coming years. It is worth recalling that today the World Health Organization (WHO) has no regulations in this field. However, with the leadership of Colombia, Argentina and other countries in the World Health Assembly held in May 2014, a resolution was adopted requesting the WHO to withdraw the approved existing guidelines for biological products and to prepare new guidelines to be submitted for discussion by the governing bodies of WHO. We are therefore at the beginning of a complicated process that will take at least two or three years. The WHO will face external pressures on this issue. There is a great risk that the new global guidelines may be influenced by commercial and not strictly by health concerns.

The decree signed by President Santos is contrary to the views that the United States and other developed countries want to impose to protect their pharmaceutical industries.

Therefore, Colombia will have to play a prominent role in the international venues to protect its national approved regulation, which in a pioneering way has managed to place the interests of public health over commercial interests.

The process of the approval of the Colombian decree leaves several lessons that need to be taken into accountto avoid compromising future regulations on this matter. The United States government’s letter not only violates Colombian sovereignty, but falsely states that the decree would be contrary to WHO regulations. It would be appropriate for the WHO to publicly say that Colombia is not violating any WHO rules or guidelines.

Colombia needs to seek international allies in the upcoming debates at the World Health Assembly in 2015. To ensure affordable access to biosimilar medicines, the governments of Colombia and other developing countries will have to maintain their position with the same clarity and determination that they have shown so far in addressing this important health issue in international fora.

German Velasquez is the Special Advisor on Health and Development of the South Centre.