|Dr Kamal K Sharma
managing director, Lupin
Lupin has made significant progress since it first rolled out its
biotech program three years ago. In an exclusive interview with
BioSpectrum, Dr Kamal K Sharma, managing director of Lupin, gives
insights into the company’s business strategy in biosimilars and the
new biological entities space.
Q Can you elaborate on
the progress of Lupin’s biotech program? What is your strategy for the
Biotech remains an
area of strategic focus and a key part of Lupin’s road-map for the
future. We started our biotechnology program three years ago and we
have made rapid progress since then. We have set up our dedicated
research and manufacturing facilities in Pashan, Pune. Lupin’s strategy
and its execution would be very global and in keeping with rigors as
demanded by regulators the world over. We plan to make our presence
felt in biosimilars, the same way we have emerged as a global generics
powerhouse. As is evident from our past behavior, our approach would be
dictated by how frameworks and regulatory pathways pan out in various
At Lupin, we have always stressed on growing organically and we will
continue to follow the same. However, that does not mean we would not
look at other modes of growth, be it strategic alliances, partnerships
or the inorganic route. All the initiatives will be in tune with our
acquisition philosophy and should be in sync with our business
road-map. Lupin is now looking forward to launch its first biological
in the Indian market by the middle of this fiscal year and going
forward, we would like this to contribute about five percent of our
global revenue by 2015.
Q Can you tell us more about the first
biological drug from Lupin?
The launch of our
first biological drug in the Indian market is most likely to happen by
the middle of this fiscal year. Lupin currently has seven proteins, all
in different stages of development. They consist of both microbial as
well as mammalian proteins, focusing on the areas of oncology and
Q What are the biotech facilities
available at Lupin?
state-of-the-art facilities dedicated to R&D in biotechnology
outside Lupin Research Park (LRP) in Pune. The vision of the research
group is to develop and commercialize biosimilars and new biological
entities (NBE) for the company. This R&D facility has already been
approved by the Institutional Bio Safety Committee (IBSC) for research
on recombinant DNA. Furthermore, this facility has also been accredited
as a biotech center by the Bioinformatic Center, University of Pune.
Our biotech program has close to 100 personnel involved in research and
support functions. We have invested a lot of resources for recruiting,
nurturing and retaining talent in this regard. The team has unmatched
domain expertise, and stellar academic qualifications. In fact, we have
recently appointed Dr Cyrus Karkaria as the new head for our
biotechnology efforts. He is the president of biotech division at Lupin
and he comes with 15 years of experience in biotech research.
Q Has Lupin entered into in-licensing
deals for biologicals products in India? What will be the company’s
development strategy towards these products?
industry experts, the market share of India in the biosimilars space
has so far been negligible. Lupin’s biotech endeavors have come a long
way since they were initiated three years ago. To optimize production
facilities for biotech drugs and considering the time required for
developing own drugs, we had in-licensed a few products from overseas
players. We have already in-licensed three products for the Indian
market and we are now in the process of in-licensing two more products.
Q Which are the overseas markets targeted
by Lupin for biosimilars and how lucrative is the Indian market for the
The US and EU
markets will undoubtedly be the lucrative ones for Lupin in the future
but we intend to start by pushing our biosimilar product line into the
Indian market and then branching out to the emerging markets. However,
our biggest growth will be on the US and EU market, where we are still
working on building competencies given the regulatory rigors that are
prevalent here. We, nonetheless, believe that these markets will offer
tremendous potential, once they fully open up to biosimilars.
Also, in the coming years, oncology, rheumatoid arthritis and diabetes
will prove to be lucrative therapeutic segments for Indian biosimilar
players, with the rise of these disease levels across the globe. For
oncology, growth will be in areas such as colon and breast cancer in
the light of the increasing rise of prescriptions in the US.
The global market for biosimilars is worth $120 billion and emerging
markets contribute 18 percent of it. The Indian biosimilars market is
set to grow at 20 percent by 2015 at par with the global growth rate.
In terms of revenues, the Indian biosimilars market is estimated to
register $2 billion by 2015 which contribute to 10 percent of the
emerging economies. This gives us tremendous scope and opportunities,
as far as selling biosimilars in the Indian market is concerned.
However, when compared to generic drugs, biosimilars are difficult to
develop and the regulatory hurdles are more difficult to clear.
Q How will Lupin Research Park augment
the company’s overall growth in the biotech space?
Lupin Research Park
is the company’s global R&D hub. The company now has over 850
scientists as compared to 550 research scientists last fiscal. The
increase in the past year has been on the drug discovery side, which we
have recently revamped. Lupin’s R&D group in Pune supports all our
markets working in conjunction with our subsidiaries, strategic
business units and business groups, helping them identify lucrative
opportunities and put in place a well-differentiated, value-based
Lupin’s biosimilar-related R&D work takes place in our Lupin
Bioresearch Center (LBC) in Pune which houses two clinics with a total
of 56 beds, a bioanalytical lab with seven state-of-the-art LC/MS/MS
systems and its own clinical chemistry lab amongst several other
capabilities. LBC conducts important bioequivalence testing exclusively
for Lupin’s generic products prior to the filing of abbreviated new
drug applications or other regulated market filings. LBC also manages
outsourced bioequivalence studies and clinical end-point studies.