With an already well-established manufacturing industry for pharmaceuticals, Turkey has been aiming to move with global trends and invest in biologics production, specifically in biosimilars.
The share of biotechnological pharmaceuticals has reached 30 percent globally, a rate that is expected to continue increasing, but the market share in Turkey last year stood at just over 18 percent. There are currently 254 forms of originator biologics under 116 licensed brands in the country, according to IEIS, and 94 forms of biosimilars under 25 brands.
“According to recent reports, the main driving force for European markets will be biosimilars and Turkey has to get on front of that; we have the necessary facilities and capabilities because Turkish companies have been investing heavily in biosimilars,” asserts Savas Malkoc, secretary general of IEIS, whose latest report reveals that 29 types of biosimilars are being produced in Turkey.
Investment in the field by Turkish companies can be traced back over a decade, but competence remains a work in progress since the production of biologics uses specialized processes that do not always resemble facilities, machinery, or equipment used to produce chemical drugs. While the number of critical tests done in the manufacturing process of chemical drugs is between 40-50, for biologics it can take 250 or more.
“Volume is key in biosimilar production, but you also need the know-how because it is more complex than traditional manufacturing,” believes Güldem Berkman from Amgen – a company that is producing biosimilars for almost 80 countries from Turkey – and suggests that Turkish companies must export to global markets.
Philipp Haas from DEVA agrees, explaining that “there is a trend towards biosimilars in Turkey and companies are trying to develop them, but the penetration continues to be underwhelming and the market remains dominated by big multinational companies.”
Amongst those international companies already competing in the Turkish biosimilars market, Amgen, Celltrion and Viatris stand out. For those companies that joined the biosimilars train years ago on the local side, choosing the right corner is strategically vital.
“It is true that Turkish companies were slow to invest in biosimilars but, fortunately, we are targeting the products that will lose patent protection after 2026-28 so we can be on a level playing field,” says Hatice Oncel from Ilko Pharmaceuticals.
For Polifarma’s Chairman, Ufuk Kumrulu, the best path forward is one away from “highly known” molecules such as monoclonal antibodies in favor of niche biosimilars: “There are more than 200 registered monoclonal antibodies (mAbs) biosimilar products in Turkey, but there are several molecules that are not registered, and we intend to be the first ones to get them to the local market and some export markets.”
Standing out from the crowd is Arven Pharmaceuticals, a company whose biosimilars development and manufacturing process has been applauded but has decided to open them up to the rest of the industry as a CDMO after an unpleasant experience. “Two years ago, we invested in trastuzumab and bevacizumab, two monoclonal antibodies, which were ready for the scale up process and first clinical studies, but unfortunately the reimbursement system in Turkey made prices for those products too low for us to consider it a feasible investment,” recounts CEO Zafer Tokzos.