From The Editor | July 24, 2017

Building Thailand's Biosimilar Industry From The Ground Up

Source: Biosimilar Development
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By Anna Rose Welch, Editor, Biosimilar Development
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Biosimilar industry

When I signed on for the Thailand media trip, I never anticipated I’d get a look at the Thai biosimilar industry through the eyes of a local biosimilar company. Thanks to Siam Bioscience, the first biologics/biosimilar manufacturer in Thailand and second biologics producer in Southeast Asia, I now have more knowledge about the country’s biosimilar landscape.

As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. These official guidelines were released in response to the launch of unsafe pseudo-biosimilars in the Thai market. Having been established in 2009, several years prior to the official biosimilar guidelines, Siam Bioscience was ready to develop and approve several biosimilars through this new pathway. 

The Thai government has been working to position the country as a life sciences hub. This mission, known officially as Thailand 4.0, strives to promote collaboration among the government, private companies, and academic researchers. Siam Bioscience is a great example of how the Thailand 4.0 mission can and has already taken shape within the country. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.

Siam Bioscience: Establishing The Company

The company was formed in 2009, several years before the Thai biosimilar guidelines (though, to clarify, Siam Bioscience’s own Epogen (EPO) biosimilar was in compliance with the new guidelines). Siam Bioscience is the product of a partnership between Mahidol University, the country’s leading medical/biosciences school, and CPB Equity Company Limited, the investment company of Crown Property Bureau, which manages the royal assets. The goal of this partnership was to create a global company in charge of R&D, manufacturing, and commercialization of biologics and biosimilars. But, obviously, a company doesn’t become a global entity overnight, and Siam Bioscience was under no illusions expanding its reach into other countries would be a quick and easy journey. It spent time focusing on just what it would need to do to achieve these goals.

We’ve seen acquisitions play a role in many of the larger organizations, but when it comes to smaller companies, especially in the biosimilar space, partnerships and joint ventures (JVs) are common. I’m thinking particularly of the successful Korean companies, Celltrion and Samsung Bioepis, which have biosimilar development down pat, but embarked on several commercialization partnerships with Big Pharma. Siam Bioscience also recognized its goal to become global would require a diversified business, as well as outside help attaining the required biologics expertise.

In particular, the company recognized the need to partner with an EU company and become a player within that market. The company currently has two JVs, one being biotechrabbit, a JV established with a German company. Biotechrabbit is a global diagnostic reagents manufacturer and supplier located in Germany. In addition to this JV, Siam Bioscience has also launched another company, Abiosim, which is located in Germany and will be an EU regulatory hub for Siam Bioscience and its other businesses. (These are just two of several other companies owned by the biosimilar maker. For instance, it’s currently working in partnership with Cuba to launch  Abinis, which will be a global, fully integrated monoclonal antibodies [mAb] company working on both innovative and biosimilar mAbs.)

In addition to JVs and partnerships, Siam Bioscience was the first commercial biopharmaceutical plant in Thailand. This facility is Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/s) GMP-, ISO 9001-, and ISO 17025- certified and is currently undergoing a few adjustments to achieve EU GMP certification.

The Company’s Forefront Goals

The company is establishing a three-phase manufacturing process. The first two phases — aseptic fill-finish production and microbial (E.coli) fermentation API production — have been completed and PIC/s- and ISO- certified/approved by the Thai FDA. Phase three, which will be mammalian cell culture API production, is under construction, expected to be in operation in 2019.

Overall, with the first two phases of manufacturing, Siam Bioscience is capable of producing up to 5 kg of biosimilar product a year. This equates to 800,000 doses a year of the biosimilar pegfilgrastim, which is one of the company’s first two products to be commercialized in Thailand. That’s well above the ASEAN demand of 20,000 doses per year. (The other product already commercialized is an EPO biosimilar.)

Besides the two already-released biosimilars, the company has an ambitious pipeline. At this point, it’s biosimilar-heavy, including rituximab, trastuzumab, infliximab, bevacizumab, filgrastim, and ranibizumab candidates — the rituximab being the furthest along in clinical development. But there are also two novel products in development: an innovative anti-influenza virus and an anti-CD6 mAb for rheumatoid arthritis and psoriasis.

Though the company has already released two of its biosimilars onto the Thai market, it plans to file its pegfilgrastim biosimilar for EU approval in 2020, with hopes for a 2022 launch.

The Importance Of The Cuba Collaboration

Siam Bioscience’s relationship with Cuba was a primary topic of discussion during our visit. As Deechongkit described, following its launch in 2009, Siam Bioscience, along with Mahidol University, went on a tour in search of biopharmaceutical technology and came away quite impressed with Cuba.

Cuba’s reputation in the life sciences industry is on the rise these days, especially given its recent developments in cancer immunotherapy. For instance, the country’s Center of Molecular Immunology (CIM) made headlines when it partnered with the Roswell Park Cancer Institute in 2016. These two organizations are now collaborating on U.S. trials of CIMAvax-EGF, a lung cancer immunotherapy developed in Cuba. (For a great article on the Cuban biotech market, check out this blog from Life Science Leader.)

Deechongkit, who previously worked for Amgen prior to being recruited at Siam Bioscience, was also familiar with Cuba. It was during his time working for Amgen that Cuba was entering into Mexico and Brazil. “It was a surprise that an island facing U.S. embargo could develop high-tech biopharmaceuticals,” Deechongkit said. “So when I had the opportunity to come work for Siam Bioscience, I recommended CIM to management, and we eventually launched a partnership with them.”

As Apiporn Pasawat, chairman of Siam Bioscience, described, it took some time to convince Cuba there was a good business opportunity in Thailand. Countries like Brazil, China, and India are alluring because of their size and aging populations. Despite the similar aging population and great need in Thailand, the chairman admitted the market opportunity for cancer and autoimmune diseases in Thailand is small. But this is where Thailand’s location and already-established trade partnerships stand to benefit Cuba.

“Luckily our partner in Cuba is operating at full capacity,” Pasawat described. “That’s why they want to engage with us to be another hub for export to Latin America, Europe, Russia, and Southeast Asia.” In particular, this partnership could help open doors for Cuba to enter nations like Indonesia or Malaysia that prioritize products from local manufacturers rather than imports. Because manufacturing is defined loosely in these countries, Siam Bioscience could easily complete fill-finish of a product at its own facility and send vials into these countries to be packaged.

From Siam Bioscience’s perspective, its partnership with Cuba has been integral for passing know-how to Thai employees. The company currently has upwards of 160 employees — more than two-thirds of which have advanced technical degrees. However, despite the highly educated base of people, there is still a need for know-how from multinational companies and more experienced biotech nations, such as Cuba.

For instance, one of the biggest challenges the company is facing now is how to build up market penetration. As Pasawat explained, “We need help getting information about other countries, and Cuba is an expert. We’re particularly looking to them for help familiarizing us with the Latin American market.”

Additional Biosimilar Challenges In Thailand

There were two other points about Thailand’s biosimilar efforts I found noteworthy: pricing and education. Because of Siam Bioscience’s role as the sole biosimilar manufacturer within Thailand, it has faced some unique challenges in both of these categories.

When it comes to pricing globally, discounts have been fairly all over the board, ranging anywhere from 15 to 70 percent across different nations. The starting discounts for biosimilars in Thailand were on the higher end. For instance, before Siam Bioscience commercialized its product (and even before it announced the product’s discount), importers slashed the prices on their imported biologics at an average of 56 percent for EPO and a more impressive 67 percent for filgrastim.

For a company like Siam Bioscience, which is a nonprofit, a primary concern is establishing a sustainable business. Being sustainable to some companies means high profits and the ability to invest in a diversified business in the U.S. and other countries. But for Siam Bioscience, “Sustainability means the capability to develop and manufacture more products down the road,” Deechongkit said. “We need profit to reinvest, but we are not going after a high return.”

For many biosimilar companies, getting products in patients’ hands seems like an uphill battle. Just as patients and physicians are hesitant about biosimilars in the U.S. and the EU, the same can be said for Thailand. In many larger nations, there are a number of trade organizations, including the Association for Accessible Medicines (AAM), the Biosimilars Council, the Biosimilars Forum, and the British Biosimilars Association, which represent biosimilar companies’ interests and promote biosimilar education to stakeholders. However, Thailand does not have a wealth of biosimilar advocates, and there are even fewer opportunities for a company to have a voice within the medical community because it is perceived as a conflict of interest. (Thai pharmaceutical companies rely on academics to speak on their behalf.)

With more biosimilar experience, more key opinion leaders from the medical community will come on board to help promote biosimilars. But until then, Deechongkit homes in on the importance of improving access to cheaper biologics. “If the innovative product should go through patent expiry and lower its price, in turn increasing people’s access, we would be out of business, and we would be happy with that,” he said. “But that’s not the case thus far. As such, I think biosimilars in Thailand will be underprivileged patients’ and the financially strapped government’s answer to biologics’ accessibility issues.”