2023-11-30

The Indian pharmaceutical industry has become one of the largest in the world today and continues an accelerated growth trajectory. However, that was not always the case. In fact, it was almost non-existent in the 1970s, when the industry was dominated by MNCs, which controlled almost 90 per cent of the domestic drug market.

Before the industry underwent a transformation in the 1980s after the Indian Patents Act came into force, only a handful of Indian pharma companies existed, one of which was founded and led by a woman entrepreneur. Since then, Biocon’s relentless pursuit of a differentiated business model has enabled it to remain relevant and sustain growth in an industry characterized by rapid change, intense competition and evolving patient needs.

Established in the late 70s, Biocon Group grew by leaps and bounds over the past few decades. In fact, just a year after its inception, Biocon was exporting a papain enzyme to the US and Europe, and within the next four years, had established a full-fledged R&D division to set up its solid-state fermentation technology. In staying committed to its vision, the Company has many firsts to its credit, and to this day, continues to challenge the status quo in its quest for high-quality, affordable healthcare.

In evolving from an industrial enzyme manufacturing company into a fully integrated biopharmaceutical enterprise that it has become today, the early steps involved working on the building blocks for the fermentation strains and processes to manufacture APIs. Although the talent pool at the time was limited, given that the technology was still niche, Biocon persisted in reaching international quality norms. In fact, auditors from several global regulatory agencies, including the US FDA and the European Medicines Agency (EMA), inspected the Company’s modest - yet capable – facilities, all of which continued to drive improvement in quality systems and processes.

By 2004, on the back of cutting-edge technology platforms, such as fermentation-based APIs and pioneering innovations and advances in biosimilars, Biocon was ready to take itself to the next level on the global platform. By this time, Syngene had been carved out as a separate R&D vertical and had begun working with some of the biggest innovator names in the industry. Driven by innovations rooted in deep scientific research and development, Biocon’s generic formulations portfolio continued to grow and consisted of synthetic and fermentation-based APIs - both high potency as well as non-potent. The Company had a novel, fully humanized monoclonal antibody in clinical development to treat head and neck cancer in India and also a yeast-based (p-pastoris) platform to commercially manufacture insulin and its analogs, paving the way for it to be among the largest insulin manufacturers in the world.

With many pioneering firsts to its name and having built a reputation for providing quality, affordable healthcare solutions, Biocon’s market cap on the first day of listing in 2004 was more than a billion US dollars. By this time, Biocon had emerged as a pioneer on many fronts. In fact, the Company developed and commercialized the world’s first Pichia-based rh-Insulin in India in 2004, drastically lowering insulin prices in the country, and just five years later, launched Insulin Glargine under the brand name Basalog® in India, providing diabetes patients with an advanced, affordable insulin therapy. Since then, it has grown to become a leading global insulins player. In fact, Biocon Biologics became the first Indian company to have three biosimilars commercialized in the US.

Meanwhile, on the API side, Biocon had become a frontrunner when it came to scale and reliability across a wide portfolio that included immunosuppressants (like Tacrolimus, Sirolimus and Mycophenolate Mofetil) to products like statins and fermentation-based anti-fungal. During this time, the Company also worked with innovator firms, helping them scale their fermentation-based proprietary APIs to take those through clinical development globally.

With a strategy to forward integrate the in-house complex APIs, in the latter half of the previous decade, Biocon forayed into the generic formulations space by developing a select few ANDAs for commercialization in the US and European markets. What followed was the launch of Biocon’s first drug product in the EU and the US in 2016 and 2017, respectively. This allowed the Company to further move up the value chain while ensuring reliability of supplies to customers and patients.

While the Company was growing and expanding this business, there were certain challenges in charting a roadmap, topmost being lack of credibility, given that Biocon did not have an established track record as a formulations manufacturer. Until then, customers knew the Company only as an API manufacturer. However, despite this roadblock, a major pharmacy chain believed in Biocon’s story of creating continuity of supply through vertical integration and reliability, calcified by the Company’s accomplishment in API manufacturing and efforts to improve access to insulins. Over the next few years, focusing on these markets helped the Company strengthen its generic formulations arsenal, enabling it to launch 15 drug products in the US, and a few in Europe, Mexico and Singapore.

As Biocon worked towards growing its generic formulations portfolio and expanding its footprint across the world, the Company leveraged its global partnerships through its legacy API businesses, entering markets like Brazil, Canada, the Middle East and China through strategic alliances. Today, Biocon has over 75 drug products in various stages of portfolio classification - commercial, tentative approvals, filed or under development.

In its quest to ensure access through quality, affordability and reliability, Biocon is today de-risking its supply chain and augmenting its manufacturing capabilities to meet the growing demand in all markets. Apart from building state-of-the-art manufacturing facilities in India that are capable of producing high-quality products at global scale, Biocon recently acquired a formulations manufacturing site in the US. The Company integrated operational capabilities to move up the value chain, introduced new therapeutic products in its manufacturing facilities and expanded production capacity further to extend access to its products to patients globally.

In tailoring its offerings to the diverse needs of patients around the world, Biocon has emerged as a global development engine of complex APIs, generic formulations and biosimilars. As it accelerates its efforts to become a global commercial engine, it is well-poised to reach new heights while staying grounded in its purpose of enabling access to life-saving medicines.