INSUBCONTINENT EXCLUSIVE:
MUMBAI: Lupin Pharma, an Indian drug maker that has made its mark in Japan, one of the toughest regulatory markets for drug companies, said
it can be market leader for its yetto-be-approved biosimilar drug Etanercept
In an exclusive interview with ET, Fabros Egros, president, Asia Pacific and Japan, said by using the combined sales force of its partner
rheumatoid arthritis, plaque, psoriasis and psoriatic arthritis.
In May Lupin submitted the biosimilar application for Etanercept to
Japanese drug regulatory authorities after the company completed a global phase 3 trial with its partner Yoshindo biologics
With a global market size of $11 billion, Etanercept is one of the most eagerly watched approvals for Lupin
It takes 12-13 months for the Japanese drug authorities to give product approvals.
Japanese drug regulators are considered to be the most
stringest in the world and often generic makers have to go through rigorous protocols to receive approval.
Biosimilars, which are follow-on
versions of complex, big biologic molecules even otherwise, require stringent trial and manufacturing protocols
launched in 1998 for the first time, so development of the molecule began in 1990
build a product that has the active ingredient to be accepted by global regulatory agencies from the design to manufacturing
expected to open doors for companies like Lupin.
The spending on biologic drugs alone in the country is $20 billion, Egros says, and the
national health insurance is looking at big savings, considering the current biosimilar drugs in the market cost 30 per cent less than the
biologic drugs.
Egros adds that biosimilar landscape in the country has been moving very fast depending on the commercial channels
For example, the switch in hospitals for oncology products has been quick, however in retail, since there is no incentive for pharmacists to
the government provided to pharmacies to switch from small molecules brands to generics will be removed and will be replaced with incentive
been struggling to grow in its biggest market, US
Japan, the second largest drug market in the world, is where Lupin has managed to register a mark among its Indian peers.
For the quarter
declined 14.2 per cent YoY to Rs 708.7 crore
With growth dented in US, its Asia Pacific business offered relief compensation recording an 8 per cent growth.
