Turkey: Shifting Priorities – Clinical Trials, Biologics, R&D Investment

There are perhaps no two words that better summarize the last few years in Turkish pharma than localization and pricing. But after years of investment and struggles, the country’s priorities appear to be shifting.

Turkey’s Vision 2023, as defined in its 11th Development Plan, has changed the government’s vision regarding pharmaceuticals as it looks to make the industry competitive at a global level. To coincide with the nation’s 100^th anniversary, the goal has been set of becoming a top ten economy in health services by 2023.

“This ambitious goal differs greatly from the former objective of becoming a manufacturing hub to supply domestic demand,” says Ümit Dereli, secretary general of the Turkish Association of Research-Based Pharmaceutical Companies (AIFD), which has 35 multinational member companies that together account for almost 50 percent of the Turkish market. “The pandemic reinforced the importance of manufacturing, but we need to think beyond the local market and move towards exports. There is a new understanding of the pharma industry in Turkey and the value it can bring; the perception is not as limited as before.”

The priorities outlined by Dereli’s counterpart at the Turkey’s Pharmaceutical Manufacturers Association (IEIS), Savaş Malkoc, seem to fit within the new scheme since IEIS is working to increase “export capacity and the competitiveness” of the Turkish pharma industry.

Both associations, however, are taking differentiated approaches.

For AIFD, representative of multinational innovators, a critical element is becoming a regional leader in clinical trials. “These areas have an economic value, but also expand a country’s capabilities and make it a stronger part of global networks. Additionally, clinical trials can bring early access to innovation for unmet clinical needs,” argues Dereli.

According to Dereli, almost all industry-supported clinical trials conducted in Turkey are led by AIFD member companies, most of them in oncology and rare diseases. Turkey currently has sufficient infrastructure to host studies from Phase I to phase III.

If the country is to achieve global competitiveness, Dereli contends, TITCK must be a globally respected regulatory authority and, fortunately, the country is moving in that direction, looking at Swissmedic, FDA, EMA and others as an example. As evidence, he describes TITCK becoming a member of PIC/S and ICH as “the most important development regarding the sector in recent years.”

For IEIS, representative of domestic manufacturers, biologics are a top priority, categorizing them as the “present and future of the global pharma industry.” In 2020, biologic products reached a market share of 25 percent in Turkey. “It is unthinkable for us to lag behind the biotech transformation considering our deep-rooted and powerful pharmaceutical industry, which has a history of more than a century. However, in the current situation, we see that our country is still largely dependent on foreign sources in this product category,” says Savaş Malkoc, although adding that “impressive” investments have been made in the field in the last 5 years.

“The amount of investment incentive certificates received by our companies in the recent period has reached USD 1.1 billion. In addition, intensive technology transfer, know-how and human resources investments are being made for these products,” he reveals, “enhanced licensing regulation that will shorten time-to-market is of utmost importance. New incentive schemes geared towards more public funding would be of help. Patients should be encouraged to begin treatment with biosimilars produced in our country.” At the moment, 29 biosimilars under 7 different brands are available in the country.

Common goal: R&D support

AIFD members’ main contribution to R&D is currently coming from investment in clinical trials inside the country, but the association has taken on the mission of fostering homegrown innovation, particularly from startup companies. That is why they are running the BIO Start-up program, “the first and only” life sciences and biotechnology accelerator program in Turkey, according to Dereli.

“We receive around 50-60 applications every year, out of which 15-20 start-ups are admitted to the program based on their competence in terms of team quality, business idea and the maturity stage like proof of concept,” he explains. A jury then selects 5 start-ups to participate in the BIO Convention, the world’s largest biotechnology event, organized in the US. “Hopefully, those start-ups will become the next success stories from Turkey… the future of innovation in pharmaceuticals cannot be limited to certain geographies, innovation is everywhere, and we cannot afford to miss out on any opportunity.”

When it comes to IEIS and local manufacturers, the focus is on R&D investment to produce value added products. “We are producing mostly generics which are not generally associated with high technology. There is a gap between the reality and perception of the Turkish pharma industry abroad. We have EMA-certified facilities that can even produce biologic products, including mRNA vaccines,” says Savaş Malkoc.

In general, Big Pharma companies spend around 15 percent of their revenues in R&D, but in Turkey the number remains around 5 percent, something that Malkoc recognizes: “All of our members are aware that the number must be increased substantially. At the same time, we believe that government policies should be re-organized drastically to accommodate more R&D spending and change the current pricing and reimbursement system.”