“Biosimilars set to gain as key biologics lose patents by 2030”

In an exclusive interview, Dr Cyrus Karkaria, President-Biotechnology, Lupin Limited shares his views on the current market trends and growth prospects of Indian biosimilars industry, company’s key offerings, ongoing initiatives, and future plans

Your views on the current state and trends of India’s biosimilars industry, and how can it capitalize on emerging opportunities?

India’s biosimilars industry is currently experiencing significant growth and transformation. The biosimilars market was valued at approximately $2.2 billion in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 25.2%, reaching around $16.6 billion by 2034. This growth rate is higher than many other countries, driven by India’s cost-effective manufacturing capabilities and strong domestic demand. The country has over 95 approved biosimilars in its domestic market, more than any other country. This high number reflects the country’s robust pipeline and active development efforts. 

The biosimilars market is highly competitive, with many players vying for market share. Market leading pharmaceutical companies, including Lupin are spearheading the change in the biosimilars space while focusing on both domestic and international markets.  A significant number of biologic drugs are expected to lose patent protection by 2030, creating a substantial opportunity for biosimilar manufacturers. The adoption of biosimilars is increasing due to their potential to transform expensive treatments into more accessible and affordable ones. There is a growing investment in biosimilar research and development, driven by both private and government initiatives. Rising prevalence of chronic diseases and increased healthcare awareness are boosting demand for affordable biosimilar treatments.

By adhering to international regulatory standards, Indian companies can streamline their entry and enhance market share in regulated markets. India’s cost-effective manufacturing capabilities provide a competitive edge. By leveraging this, companies can offer high-quality biosimilars at lower prices, making them attractive in both domestic and international markets. Collaborations with global pharmaceutical companies can help Indian firms gain access to advanced technologies and markets, enhancing their global footprint.

Which factors have shaped Lupin’s biosimilars portfolio and global strategy?

Lupin’s biosimilars portfolio and global strategy are driven by a combination of factors which enable Lupin to capitalize on emerging opportunities and enhance its global presence in the biosimilars industry. The company has made substantial investments in research and development, and established multiple research centers, including Lupin Research Park, and Lupin Bioresearch Center. Lupin has developed end-to-end capabilities: “Vial-to-Vial” for biosimilar development.

Lupin has had a strong track record of successful scale-ups and cost-effective, high yielding manufacturing processes. It has invested in building world-class manufacturing capabilities and adopting a robust Quality culture, to sustain the competitive edge in the long term. The company has formed strategic partnerships with international organizations and research institutions to enhance its biosimilars development capabilities along the value chain. Additionally, collaboration with local companies in US, EU, Japan, MENA and LATAM has helped Lupin expand its commercial footprint and reach in global markets.

Adherence to global standards has been the Mantra at Lupin! Lupin’s biosimilars are developed in compliance with international regulatory standards, including those set by the US FDA, EMA, WHO, PMDA, and Indian regulatory bodies. Lupin’s biosimilars meet stringent quality and safety requirements, facilitating smoother market entry and acceptance in regulated markets. The company has built a strong pipeline of biosimilars targeting various therapeutic areas including autoimmune diseases, oncology, and ophthalmology, among others. Key products like Etanercept (Nepexto®/Rymti), Filgrastim (Lupifil®), Peg-Filgrastim (Lupifil-P®), Ranibizumab (Ranieyes) have been gaining approval in multiple markets, showcasing Lupin’s ability to develop and commercialize complex biosimilars. 

In what ways is Lupin integrating advanced technologies to improve bioprocessing and accelerate the development of recombinant proteins and vaccines?

Lupin is leveraging several advanced technologies to enhance bioprocessing and accelerate the development of recombinant proteins and vaccines.  The company utilizes optimized cell line technology platforms to improve the efficiency and yield of recombinant protein production. We employ high-throughput screening methods to expedite the selection and assessment of recombinant proteins. The automation and digitalization are integral to Lupin’s bioprocessing strategy. Automated systems for cell culture, purification, and quality control enhance consistency and efficiency, while digital tools for data analysis and process monitoring improve decision-making and process optimization. Lupin is exploring modular bioprocessing systems to facilitate flexible and scalable manufacturing. These systems allow for easier transfer of bioprocessing operations across different sites and can be rapidly adapted to meet changing production needs.

“Lupin’s biosimilars are developed in compliance with international regulatory standards, including those set by the US FDA, EMA, WHO, PMDA, and Indian regulatory bodies.”

What is the transformative role of Artificial Intelligence (AI) and Machine Learning (ML) in optimizing bioprocessing workflows?

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing bioprocessing workflows in several transformative ways. AI and ML can analyze historical data to predict process outcomes, such as product yield, quality, and stability. This predictive capability allows for proactive adjustments to process parameters, minimizing deviations and ensuring optimal performance. ML algorithms can identify optimal process parameters by analyzing vast datasets and experimental results. This reduces the need for extensive trial-and-error experiments, accelerating process development and reducing costs.

How do you look at the impact and advantages of Single-Use Technologies (SUTs) in modern biomanufacturing?

Single-Use Technologies (SUTs) minimize the risk of cross-contamination by using disposable components that are pre-sterilized and discarded after use. This is particularly beneficial in multi-product facilities where contamination between batches can be a significant concern.  SUTs offer greater flexibility and scalability in biomanufacturing processes. They allow for rapid setup and changeover between production runs, making it easier to adapt to changing market demands and scale up or down as needed. The use of disposable components reduces the time required for cleaning and validation, leading to faster turnaround times between production batches. This accelerates the overall production process and improves efficiency.

Despite these advantages, SUTs also face challenges such as material compatibility, leachables and extractables, and supply chain reliability. Addressing these challenges is essential for the broader adoption and success of SUTs in biomanufacturing. Many modern facilities use a hybrid approach, combining the benefits of both technologies to optimize their operations.

What is the potential of Microfluidics and 3D Cell Culture to revolutionize drug discovery and development?

Microfluidic platforms enable high-throughput screening of drug candidates by processing small volumes of samples quickly and efficiently. This accelerates the identification of promising compounds and reduces costs associated with traditional screening methods. Microfluidics allows for precise control over biochemical reactions and processes, facilitating the miniaturization and automation of laboratory techniques. 

3D cell culture technologies create environments that closely resemble in-vivo conditions, providing more accurate models for drug testing. 3D cultures, including spheroids, organoids, and organs-on-chips, offer better insights into drug efficacy and toxicity. These cultures are valuable for disease modeling, allowing researchers to study disease progression and drug effects in a controlled setting. By providing more accurate human-like models, 3D cell cultures can reduce the reliance on animal testing. This not only addresses ethical concerns but also improves the relevance of preclinical testing to human biology.

Lupin has emphasized the development of biosimilars for regulated markets. Could you elaborate on the progress and future plans in this area?

We have made significant strides in developing biosimilars for regulated markets, with a clear focus on expanding our global presence. We have successfully obtained regulatory approvals for several biosimilars in key markets. For instance, biosimilar Pegfilgrastim (Armlupeg®) received approval from Health Canada in 2024 . Additionally, our Etanercept biosimilar (Nepexto®) has been launched in 20+ countries globally, including highly regulated markets including EU, Japan and Canada. 

We will continue to expand our product portfolio with the filing of Marketing Authorization for three biosimilars in regulated markets in 2025 and 2026. We also have an early phase pipeline of 5-6 products, slated for clinical development and launch in next 4-5 years. By leveraging its cost-effective manufacturing capabilities and strategic partnerships, our mission is to enhance access to high-quality, affordable biologics worldwide. We will also differentiate our product offering through the development of next generation devices and enhancing our core capabilities across the value chain. Drawing inspiration from evolving regulatory guidelines and early scientific  advises, we shall continue to optimize clinical trial requirements to enhance the development cost and time for next wave of Biosimilars. 

In addition to being a Biosimilar player, we also provide our clientele with CDMO services for custom Research and Manufacturing. Our state-of-the-art manufacturing & research infrastructure, skilled talent pool and relevant expertise makes us a trusted partner of choice in the biotech CDMO space. Lupin stands committed towards expanding access to affordable healthcare solutions globally and is taking notable strides with a strong sense of purpose!

*This interview was first published in the April 2025 edition of BioVoice eMagazine.