Indian drugmakers muscle in on biosimilars development
Therapeutic proteins (biosimilars)
manufactured from natural sources and providing solutions for several unmet
clinical needs are the next big thing in India. Adoption, growing investment
and deal making in the global arena has got several Indian companies tuning in
to biosimilars, reports The Pharma Letter’s India correspondent.
Though the high price of biologic therapies
is a great burden on healthcare costs globally and a majority of patients in
India still cannot afford these drugs, Indian drug majors are stepping up
investments to tap the growing opportunities overseas.
While Cipla recently signed a memorandum of
understanding to set up South Africa's first biosimilars manufacturing facility
at a cost of nearly $91 million, Intas Pharma is gearing up for US approval for
its Neulasta (pegfilgrastim) biosimilar this year.
Amgen’s Neulasta is the company's second
largest selling white blood cell boosting medicine, and reportedly brought in
sales of $1.15 billion in the second quarter of this year. Intas is set to
launch a copy of the drug in the US market, which it has developed with
Canada's Apotex.
The Ahmedabad based Intas is a privately held
company, and backed by two leading financial investors, Temasek and
ChrysCapital. It has the largest commercialized portfolio of biosimilars in
India and is the first Indian drug company to launch a biosimilar in the
European Union.
The company is looking to spend around $30
million for research into trials of biosimilars. With an annual turnover of $1
billion, Intas draws 60% of its annual revenues from international operations.
The interest of Indian drug companies in this
segment is evident as drugs worth $90 billion are set to go off patent in the
Europe and the USA over the next 10 years.
Biosimilar
wave
Biosimilars are an attractive opportunity,
with analysts expecting the global market to be close to $240 billion by 2030.
At that time, it is estimated that close to half of this market size would be
in emerging economies, with the Indian market capable of reaching $40 billion.
More than 10 large pharmaceutical companies
in India have focused investments on biosimilars and the country boasts having
a very active development pipeline. More than 60 biosimilar drugs are already
approved in India.
India's Biocon is the only well-equipped player to
participate in first wave of biosimilar launch, with four advance stage
products in the pipeline. Roche’s Herceptin (trastuzumab) is one such drug,
whose patent expired in 2014.
In August, Mylan and Biocon said the European
Medicines Agency has accepted for review Mylan's marketing application for
biosimilar trastuzumab, which is used to treat certain HER2-positive breast and
gastric cancers. This is the second biosimilar submission developed by the
partnership that has been accepted for review in Europe. Last month, Mylan's
application for biosimilar pegfilgrastim was accepted for review by the EMA.
Mylan and Biocon, which have co-developed the biosimilar, anticipate that this
may be the first trastuzumab biosimilar filing accepted by the EMA for review.
Globally, there are 37 biosimilar version of
the Herceptin drug in clinical pipeline. Currently, there are four biosimilars
in Phase-III trials which are expected to be commercially available over the
next five to eight years.
Three biosimilar versions of Herceptin are
commercially available in India for the treatment of breast cancer. In May this
year, the Indian government capped the price of trastuzumab at 25% lower than
the innovator Roche's drug.
Many
players in the sector
Biocon has four biosimilars: trastuzumab,
adalimumab, pegfilgrastim and insulin glargine. Biologics have registered
growth of 26% for the company, based on healthy supplies of trastuzumab and
insulin glargine in the emerging markets.
Two of its biosimilars - trastuzumab and
pegfilgrastim - are also under review by Europe’s EMA. Biocon has indicated it
will be filing at least four biosimilar applications for review in the Europe
as well as the USA. The four biosimilars have an addressable market size of $30
billion.
On the other hand, Dr Reddy's too has a wide
portfolio, with products like rituximab, filgrastim, darbepoetin and others. Zydus Cadila
has nine biosimilars and recently launched the world's first biosimilar version
of arthritis drug adalimumab.
Steady
increase In India’s share of biosimilars
India's share of biologics has been steadily
increasing over the years. In 2002, it was 11%, while in 2007 it was around
15%, according to data from IMS Health. By 2012, India's share of biologics
jumped to 18%, and by early next year, it is expected to be 20%.
Similarly, the country's share of biosimilars
and non-original biologics is also on the rise. In 2002, it was around 0.3% of
$46 billion, while in 2007 it was 0.5% of $106 billion, IMS Health data showed.
In 2012, it was 1% of $169 billion while by next year, it is expected to be
2-5% of $221 billion.
Expiration of patents and greater regulatory
support has only aided the trend. With patents for over six top selling biologics
like Humira, Avastin, Enbrel, Rituxan/MabThera, Herceptin and Remicade expiring
between 2015 and 2020, it allows manufacturers of biosimilars to seek US Food
and Drug Administration approval for generic biologics.
Globally, more than 160 biosimilars have been
reported in different stages of development for these six best-selling
biologics.
Gautam Kothari, associate director of
research and equity firm Equirus Capital, says biosimilars tend to offer a
higher margin, and that biologics' patents worth $55 billion are set to expire
by 2020.
Indian companies have taken note. The Indian
biosimilars industry was close to $300 million in 2015 with domestic sales
pegged close to $250 million. Sales have been growing at an annual rate of 14%.
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