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‘Lupin has gained significant momentum towards development of biosimilar products with primary focus on regulated markets’

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Lupin Biotech, with a new-age R&D facility in Pune, is developing and commercialising biosimilars globally. The successful development of Etanercept biosimilar is a case in point. Dr Cyrus Karkaria, President-Biotechnology, Lupin divulges more details about the company’s projects in this arena, its focus areas, future plans of expansion and more, in an exclusive interview with Lakshmipirya Nair

How is biotech propelling India Pharma Inc’s progress? How will it contribute to India Pharma Inc’s efforts to become a value-led and innovation-driven industry?
Biotechnology is the new sunrise sector in India and is poised to take the country into the next big league of internal and international investment. The Indian biopharma industry is on the brink of becoming a major global force in terms of manufacturing and research capabilities. We are witnessing dynamic changing trends such as large acquisitions by multinational companies in India, increasing investments, deeper penetration into the rural markets, growth and availability of healthcare and incentives for setting up special economic zones (SEZs). R&D in India is getting more innovative with the first set up of Made-in-India biologics approved. A well-defined regulatory framework, along with an emerging stringent IPR regime is also contributing to this trend. Foreign investment has driven clinical trial outsourcing along with strong clinical trial data management.

India is leading the global biosimilar pipeline, with the largest number of biosimilar products launched in the country and emerging economies. India alone has over 40 biosimilar products in the market. Domestic companies are also aggressively targeting entry into regulated markets. In the last three years, Indian biopharma has achieved a remarkable feat with five biosimilars approvals in EU and two approvals in the US. The final imperative for India is to create a conducive environment for global partnerships to enable joint IP generation, harmonise Indian regulatory guidelines to meet global norms and smooth movement of biologics as well as leverage better markets for biotech products and processes.

How huge is the market for biosimilars globally? What are the factors boosting its growth?
The market size for biosimilars in 2018 was $3.8 billion and is projected to be over $20 billion by the close of 2024. Due to the patent cliff coming up in the biopharma industry, the next wave is focused towards the development of biosimilars. Some of the other factors bolstering the demand for biosimilars include cost-effectiveness, rising prevalence of chronic diseases (such as autoimmune diseases and cancer) and growing geriatric population.

According to US FDA’s latest guidelines meant for biotech products, biosimilars are poised to play the role of a game-changer. US FDA’s guidelines also aver that biosimilars can achieve an interchangeable status, which means they may be substituted for the reference biologic without a prescriber intervening at any stage.

But for this to happen, extensive clinical studies post original trials are required to establish bio-similarity, in the first place.

How important is the biopharma segment in Lupin’s roadmap for the future? How are you strategising to leverage the enormous potential in this sector?
Lupin Biotech has been on a growth trajectory for the last few years with streamlining of its vision, enrichment of pipeline products and strengthening of its globalisation strategies. Despite being a late entrant to the biosimilars segment, Lupin over the last 10 years has gained significant momentum towards the development of biosimilar products with a primary focus on regulated markets. “Product development to meet the highest regulatory standards” has been the mantra at Lupin, leading to the establishment of strong capabilities across the product value chain. Comprehensive regulatory and clinical strategies are being devised, based on early advice from US FDA, EMA, Health Canada, TGA, PMDA etc. to harmonise regulatory expectations across geographies and establish totality of evidence.

Lupin successfully designed and completed a global, multi-centric clinical trial for Etanercept across EU, Japan and India. A recent partnership with US drugmaker Mylan for commercialisation of Etanercept in Europe, Australia, New Zealand and Asia is a shot in the arm for the company. Lupin has launched Etanercept in Japan in mid-2018 through its Japanese partner and is gearing up for Etanercept launch in EU by mid-2020. Multiple US FDA centric clinical studies have been strategically designed and initiated for Etanercept in parallel.

The successful development of Etanercept biosimilar for regulated markets is a stepping stone towards Lupin’s aim to establish itself as a global biopharma player. The experience of developing quality biosimilars can now be deployed speedily to gain a first-mover advantage for early-stage projects. We believe that our efforts position us rather well to remain ahead in the high risk, high reward biosimilar race!

Tell us about your key research and innovation projects in this arena and the unmet medical needs that they would tackle.
Lupin’s biosimilar pipeline encompasses seven blockbuster molecules for diverse and niche therapeutic indications such as oncology, auto-immune, ophthalmology and osteoporosis. The pipeline has been enriched with an eye on meeting unmet medical needs and gaining early entry in the target markets. Lupin prides itself in developing products with excellent biosimilarity to the Reference Medicinal Products, in terms of strong CMC and Clinical profile. The product development conforms to US FDA, EMA, PMDA, WHO and Indian biosimilar guidelines and is aligned with the global regulatory needs to target regulated markets. The product development has been supported by innovative, high yielding and proprietary expression systems, innovative process designs and orthogonal methods. Novel formulations have been successfully developed for multiple products along with user-friendly drug delivery devices. Lupin continually strives to design “differentiation” strategies, to make biosimilars affordable and accessible to the masses. Lupin Biotech envisions conquering many more developmental milestones in the near future, with its world-class talent pool and gaining “first-mover advantage” through careful selection of new products in their developmental pipeline.

What kind of investment would you look at in the next three years to gain a stronger foothold in this growing sector?
The estimated cost of developing a biosimilar for the global markets is being estimated at $100-200 million while developing traditional non-biologic generics costs about $3-$5 million. Enrichment of early phase pipeline is always on Lupin’s radar, with a clear focus on faster development timelines and proven biosimilarity of the product. Cell line technology platforms are continually explored in-house for selection of high producer clones. From an early stage of development, there is an unwavering eye on optimising the cost of goods to enable affordable pricing of biosimilars and gain a sustainable competitive edge. With a relentless focus on speed and productivity along with unflinching incorporation of “Quality by design”, the paradox of high yield and high product quality has been made defunct at Lupin Biotech.

Lupin has built a world-class biotech facility in Pune with separate suites for microbial and mammalian products and designed as per regulated market expectations. Last financial year, Lupin Biotech faced cGMP audits from stringent regulators like PMDA and EMA for the manufacture of Etanercept drug substance and drug product in its mammalian facility. The biotech team successfully handled each of these critical audits and received GMP certification from both agencies.

Lupin Biotech is making substantial investments towards the expansion of its manufacturing base and to meet the spiralling global demands for mammalian products. It is constantly improvising and setting best in class development and compliance standards internally, to prepare for US FDA centric product development and submission in the coming years. Notable investments are also made during the execution of global clinical trials and best efforts are made towards harmonisation of requirements from different regulatory agencies.

Which are the leading areas/segments that are driving India’s biotech/biopharma sector?
The three largest biologic therapy areas (autoimmune, diabetes, oncology) command half of all biologic revenue, globally. Biologics are entering therapy areas where they have not been present historically, such as asthma, dyslipidaemia, and allergy. They will expand treatment options for patients in these indications, many of which are underserved. Currently, mAbs hold the lion’s share of the biologic market sales and remain the largest technology class within the biologic pipeline. However, the mAb dominance we see today could be outperformed by novel biologic technologies like Antibody drug conjugates, Antisense/RNAi, Gene therapy and Cell therapy. Many biologics are also being developed with novel delivery systems with inhaled, implanted and oral versions targeting improved patient compliance.

India is becoming one of the most favoured destinations for collaborative R&D, bioinformatics, contract research and manufacturing and clinical research as a result of growing compliance with internationally harmonised standards such as Good Laboratory Practices (GLP), current Good Manufacturing Practice (cGMP) and Good Clinical Practices (GCP). The future looks bright and promising with many Indian companies developing a long term vision and gradually investing in new biological entities (NBEs).

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