Fostering a Culture of Innovation

Our focus on innovation helps us develop new and high-quality generic medicines to offer accessible healthcare and improve lives. In FY 2020-21, we invested INR 14,324 million in research and development. We firmly believe that our investment in R&D will lead to sustainable value creation both in terms of top line growth and in improving access and affordability of our medicines to patients across the globe.

We aim to enrich our portfolio by identifying and developing new and improved products as well as partnering across the value chain to achieve scale and impact.

R&D Infrastructure and Key Developments

With R&D centers in seven locations across the globe, employing over 1,400 personnel, we continuously innovate by utilizing advanced technologies, superior competencies and strategic alliances. We are proud of our state-of-the-art R&D Lupin Research Park (LRP) at Pune, India, which functions as the hub of our global research activity. The campus houses our generic research unit encompassing API and finished product research, and our Novel Drug Discovery and Development (NDDD) unit.

Over the years, we have transitioned from an oral solids portfolio to encompassing a wide array of complex generics such as injectables, biosimilars, and inhalation products.

We are exploring advanced device development platforms in the inhalation segment to enable better patient compliance.

Bioclinical research: The Lupin Bioresearch Centre (LBC) is located in Pune. The facility has continuously maintained outstanding performance on regulatory compliance. We conduct both in-vitro and in-vivo bioequivalence (BE) studies required by regulatory agencies across the globe. We have conducted 36 in-vivo pivotal BE studies, 69 in-vivo pilot BE studies and 11 in-vitro BE studies in FY21 and have cumulatively established over 330 validated analytical methods to date.

Complex injectables platform, Nanomi: Nanomi, Lupin’s Netherlands subsidiary is a leader in the field of microsphere and nanoparticle research and development of long acting injectables. Nanomi’s expertise lies on its Microsieve technology. We have leveraged this expertise and achieved significant milestones in the last year with respect to clinical trials and scale up activities for our long acting injectable assets.

Inhalation Research Centre, Coral Springs: Lupin’s Inhalation Research Centre at Coral Springs, Florida, is a specialized facility focused on research and development of inhalation products for the treatment of asthma, chronic obstructive pulmonary diseases (COPD) and other respiratory ailments. Coral Spring’s expertise has allowed us to set our vision to become a leader in the inhalations space.

We have achieved the following milestones at Coral Springs in the last fiscal year:
Gx ProAir ANDA approved by FDA
Gx Brovana ANDA tentatively approved by FDA
Gx Dulera ANDA submitted to FDA
Gx Perforomist ANDA submitted to the FDA
Gx Fostair MAA submitted to BfArM
Gx Spiriva MAA submitted to MHRA
Gx Clenil MAA submitted to MHRA
Successful USFDA inspection of Coral Springs site

Managing Intellectual Property

We are committed to enhancing our product portfolio by securing intellectual property rights on innovations across our global R&D. The value of our patent portfolio is testament to our commitment.

Managing Intellectual Property
  • 886 Patents are currently active (API, Formulation, NDDD, Biotech, Brand)
  • 36 Patents secured
    in FY21
  • 2,983 Trademarks
    registered to date
  • 437 ANDA filings; 288 Approvals;
    49 FTFs; 18 exclusive FTFs to date
  • Filed 15 ANDAs comprising oral, injectable, ophthalmic, inhalation and dosage forms
  • Filed one PEPFAR
    ANDA in FY21
  • ANDA filings for the year include 5 Exclusive First-to-File (FTF) and 4 Shared FTF products
  • Received approval for 19 ANDAs & 1 NDA from USFDA in FY21
  • Filed 16 generic products in markets such as EMEA, LATAM and Canada & received 10 approvals in FY21

In FY21, Lupin settled 11 US litigations and one UK litigation. Further, Lupin received favorable US court decisions in our Kerydin® and Tecfidera® patent challenges in the US and a favorable German court decision in our Truvada® SPC challenge.

Novel Drug Discovery & Development

At the cutting edge of innovation, we are developing a pipeline of highly differentiated and innovative new chemical entities within focused therapy areas, including Oncology, Immunology and Metabolic Disorders. Our partnership with Boehringer Ingelheim to develop a clinical stage MEK product for difficult-to-treat cancers has moved ahead, bringing Lupin subsequent milestones. Similarly, our partnership with Abbvie continues to perform.

Our strong oncology pipeline includes frontier approaches of exploiting immunology, synthetic lethality, epigenetic changes, and cancer metabolism. We are committed to successfully translating these R&D efforts from bench-tobedside. This approach is tumor agnostic and aims to treat patients based on specific gene mutations/ alterations regardless of cancer type.

Biosimilar
Research

Despite challenges this year, we achieved several milestones and witnessed significant progress in developing biosimilars. We received market authorization and successfully commercialized biosimilar Etanercept (Nepexto) in key EU markets with our marketing partner Viatris. Our biotech site in Pune, which manufactures Etanercept, was inspected by the EMA in March 2021. Additionally, our Etanercept product was commercialized in India, based on prior approval received from DCGI.

We continually enrich our biosimilars portfolio by identifying and developing new products and leveraging partnerships across the value chain. Our pipeline includes:

  • Peg-filgrastim: We achieved a notable milestone with our oncology product through the submission of our BLA (Biological License Application) to the USFDA at the end of FY21.
  • Our Ranibizumab Indian Phase III clinical study was successfully completed and therapeutic equivalence to the reference product was achieved, in terms of primary and secondary endpoints. Product launch in India is targeted in FY22. The Global Phase III study is ongoing, with sites in India, the EU and the US.
  • Our Aflibercept biosimilar development has picked up pace in FY21.

Protecting Our Intellectual Property

We are driving digital transformation across our organization, embedding new technologies to protect our intellectual capital.

Although new age technologies have simplified the research process, they have also introduced newer ways that could lead to information breaches and theft of intellectual property. We design effective IP strategies and implement measures to prevent product piracy and counterfeiting.

Our Information Security Management System KAVACH ensures effective security controls and safeguards and creates awareness about data security. KAVACH protects our information through a framework for policies, procedures, and guidelines. We are accredited with ISO/IEC 27001:2013 on Information Security Management Systems at our Head Office, Pune Research Park, manufacturing facilities at Biotech, Mandideep and Indore; we intend to add Ankleshwar and Vizag to this certification list.

Our commitment to information security is extended across our global locations under the project brand name ‘SHIELD’ to provide information security assurance.