BOGOTA, Colombia – After years of delays on issuing a regulation for biosimilars, the Peruvian Directorate General of Medicines, Supplies and Drugs (Digemid) is moving forward with regulations that would pave the way for biosimilars to enter the Latin American country, but the pharma sector is concerned with the proposed timings for registration and re-registration of this relatively new category of drugs.

In 2011, the country issued its policy for the registration, control and health surveillance of pharmaceutical products, medical devices and sanitary products. At that time, the newly introduced rules established a term of 180 days to issue the guidelines required to regulate the entrance of biosimilars to the Peruvian market.

However, the government failed to meet the deadline and over the past months Digemid has been publishing and modifying the drafts with the guidelines that would regulate the filing and content of the required documents to register and re-register biosimilars. The latest draft was distributed on Aug. 20. They follow a first version developed in 2013 and circulated in February.

"These drafts are very different from those from 2013," said Augusto Rey, president of the Peruvian National Association of Pharmaceutical Labs (Alafarpe) in an interview with BioWorld Today. Alafarpe represents both domestic and international labs.

Digemid also published the draft that would regulate the therapeutic equivalence studies for interchangeability of drugs. It is open for comments until Nov. 12, 2014.

Alafarpe welcomed the publication of the drafts after the long wait of over three years but is not altogether happy with the shape they have taken.

"We received the drafts as a very positive progress from our country´s health authority, because it is complying with what was mandated in the [2011] rule," Rey said.

"[The rules are] away from what is established by the World Health Organization (WHO) [because] they set a time frame of four years for the drugs that are already in the market to adapt to the new rules, but without establishing criteria or times, aspects that are necessary to file certain technical requirements of quality, preclinical studies and clinical trials indicated by the WHO, in order to demonstrate the quality, safety and efficiency in the market."

In February, the various guilds provided feedback on the proposed regulations.

"Until now [Digemid] hasn't said anything about [the comments]," Rey said. "[Our comments] are based on international standards from U.S. FDA, EMA and countries with high health surveillance."

It is still unknown the date when the government will enact the new rules based on the drafts.

Another point of discussion in which Alafarpe doesn't agree with the national authority is the time frame given to biosimilars that have already passed the registration procedure under the current rules.

"Those would also have an adaptation period as the ones that have the [biosimilars] that are already in the market. The ideal would be for those to comply with the new regulations before entering [the market]," Rey said.

QUALITY, EFFICIENCY AND SAFETY

Alafarpe's concerns are linked to patient safety.

"We understand that a period of adaptation is required, but that [of four years] is a period of time in which many patients will be consuming medicines whose efficiency and safeness is not proven," he added. "WHO´s guidelines do not establish it to be that way."

However, the new regulation would be of great value in terms of safety, Rey said.

"The positive side of this guideline is that it creates a quality, safety and efficiency control of the drugs that enter or are in the market, in benefit of the whole population. Thereby, there will be a greater control of biosimilars.

"Our message to the community [is a call] to issue clear guidelines that comply with international standards, for the Peruvian market to count with products that comply with three basic rules of a pharmaceutical product: quality, efficiency and safety. The same ones that are subject to the Medicine Policy as established in the Law of Health," said Rey. "We reaffirm our commitment to working in favor of the health of the Peruvians. It is with this objective that we make our comments [to the draft]," he added.

Neighboring Colombia recently issued a decree that established biotech regulation for the pharma industry in the country. It took more than two years and five drafts in the midst of a heated debate between the government and international pharma companies, until it became real. (See BioWorld Today, Sept. 23, 2014.)

In Colombia, a "third pathway" allows producers and importers to use an express pathway to market biosimilars referenced from biotech products, once their patents expire. No pre-trials or clinical trials are required.

"[In Peru, the Colombian case] has been discussed and the advantages and disadvantages of the third pathway have been analyzed. But under this context, Digemid has opted for following the guidelines of high health surveillance countries, such as U.S. FDA and EMA, while looking for a better benefit for the Peruvian population," said Rey.

"We need to work [together] as a country to align ourselves to the latest technological developments and be prepared for global changes."

Editor's note: The just-published Biosimilars: A Global Perspective of a New Market Opportunities, Threats and Critical Strategies 2014 is a comprehensive global analysis and data resource defining who's who in biosimilars. The new market report details more than 700 biosimilars already approved or in pipelines and profiles the 245 companies developing the drugs.