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Taiwan Biosimilars Industry Starting To Take Shape
TAIPEI, Taiwan – With a number of novel biologics looking good in late-stage multisite FDA- or
EMA-authorized clinical trials, Taiwan’s biopharmaceutical sector is starting to fulfill its early
promise, rewarding the faith of its backers – both government and private sector – after decades
of slow progress. Local production capacity is now ramping up; at least seven companies have
their own manufacturing facilities and more are on the way.
Fueled in part by cash from a sustained local stock market rally around local biotech stocks, that
growing capacity matched by renewed confidence has resulted in an increasing number of
companies entering the biosimilars space.
It takes a brave CEO to commit to a biosimilars strategy. The huge demands of time and money –
average development cost is about $250 million – are not so far off those for developing novel
biologics, with the added uncertainty of highly viable and unpredictable worldwide regulatory
conditions. But one unique option open to Taiwan is China. Its biologics and biosimilars
regulatory guidelines are still relatively undeveloped and favor local companies over those from
overseas, but Taiwan hopes that the signing in 2010 of the Economic Cooperation Framework
Agreement (ECFA) between Taiwan and China will eventually allow Taiwan companies in the
biosimilars space a better chance than those of other countries at cracking that lucrative market.
The first Taiwanese company to develop a biosimilar, and currently the farthest along the
development pathway, is Mycenax Biotech Inc., with its Enbrel (etanercept, Amgen Inc.)
biosimilar Tunex, currently in a Phase III trial in Taiwan, with completion expected within two
years and market entry in three.
For Mycenax, the development road has been rocky, from problems with its Korean contract
research organization shelving its rollout schedule in north and west Asian markets, to its longterm plan for U.S. market entry being hit, along with many other Asian Enbrel biosimilar
developers, when in May 2010 Enbrel was granted a 16-year U.S. patent extension. A testament
to its flexibility, Mycenax was able to shift its strategy to a Taiwan-first-China-second market entry
plan. With market size for Tunex in Taiwan in 2012 estimated to be about NT$1.2 billion (US$41
million), and with Mycenax expecting Tunex to sell at a price point up to 90 percent of the
reference drug and take about 25 percent market in peak sales, the opportunity is not spectacular
but it’s a reasonable start.
“Building on this, we will start developing two to three new biosimilars targeting autoimmune
diseases within the next few years,” said Winters Fu, a spokesperson for the company.
Other Players Advancing
Mycenax is the only local company with a biosimilar in clinical trials of any sort. However, a
handful of other companies have drugs at the preclinical stage, or have announced plans to at
least begin a biosimilars development program.
One such company is contract manufacturer JHL Biotech Inc. Formed only a year ago with
investment backing from Kleiner Perkins Caufield Byers, Sequoia Capital and Burrill & Co., JHL
Biotech has hit the ground running with its process development, pilot plant and clinical
manufacturing facilities already open and operating in Hsinchu, Taiwan, with a large-scale
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manufacturing facility in the Biolake science park of Wunan, China, set to open in 2015. With an
unnamed biosimilar already in development in-house, the company stated recently that its
midterm goal after reaching its CMO goals is to be a biosimilars-focused company, with a longterm goal of developing novel biologics.
Another is Pharmaessentia Corp. The company has a number of biobetters or novel biologics in
its pipeline via its “PEG” protein drug development platform, as well as a biosimilar, PEG-GCSF.
“PEG-GCSF will be a biosimilar to Neulasta [pegfilgrastim, Amgen] for chemotherapy, although
we do have a biobetter version in development as well,” Pharmaessentia founder and CEO KoChung Lin told BioWorld Asia.
The company has both Taiwan and U.S. investigational new drug application (IND) filings
planned for the end of 2014.
A company with a China-focused biosimilar plan is allergy and autoimmune disease specialist
Fountain Biopharma Inc. Founded in 2010, the company secured NT$1.5 billion in first round
funding in 2011, and it listed on Taiwan’s “GreTai Emerging” stock exchange in 2012. The
company is working with Hong Kong-based Morningside Venture Group, together with Lonn
Ryonn Pharma Ltd., of Shenzhen, China, for the clinical development of its Xolair (omalizumab,
Roche) biosimilar in China. Together with Lonn Ryonn Pharma, Fountain Biopharma has a CFDA
IND filing planned for 2014.
There are a few other companies at the early stages of a biosimilars development strategy,
including TTY Biopharm Co. Ltd., of Taipei, which is reportedly working on a biosimilar. Tanvex
Biologics Inc., considered a joint Taiwan-U.S. company with operations in both countries and a
cGMP manufacturing facility in San Diego, is another firm reportedly with a biosimilars
development program. Tanvex CEO is Hardy Chan, co-founder of Taiwanese API manufacturer
Scinopharm. And Eirgenix Inc., with facilities including both 500-liter mammalian and 100-liter
microbial cell production lines newly acquired from the government-funded Development Center
for Biotechnology (DCB), has said it intends to utilize its facilities for biosimilar development, both
as a CMO and for the development of its own assets. There is also United Biomedical Inc. Asia, a
developer of “designer vaccines” for both human and veterinary use, which has an EPO
biosimilar in the works.
As for overseas companies, Sandoz International GmbH has the only biosimilar so far approved
in the Taiwan market, with Omnitrope (somatropin) granted that status in May 2010. Although,
according to Taiwan regulators, there are at least six drugs from overseas companies currently in
clinical trials for eventual market approval on the island.
Taiwan’s biosimilar regulatory guidelines are based on EMA regulations. An interesting
comparison is with China, which doesn’t have a specific biosimilars regulatory pathway;
biosimilars in that country have to go the novel biologics regulatory route. And there are certain
conditions which make life difficult for overseas companies. As Willie Lin, chairman and general
manager of Fountain Biopharma, explained, firms have to partner with local companies at the
earliest stages if they want to market a biosimilar in China.
“For a biosimilar to be registered in China, not only must it be manufactured at a cGMP plant in
China,” he said, “but material for all clinical trials must also be made locally.”
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