Deloitte predicts that the global market for biosimilars will reach between USD 25 and 35 billion by 2020, driven by some key global biologic drugs facing loss of exclusivity in the next few years and an increasing global focus on improving healthcare access and the cost of care. Against this backdrop, a few of the most technologically advanced Indian pharma companies – Biocon, Zydus Cadila, Wockhardt and Dr. Reddy’s – are scaling the value chain to capitalize on this highly profitable area both in India and abroad.

“[Ogivri™] was a drug that was approved in India in 2014 and I am very pleased that our strategic intent, which was to provide affordable access to patients in the developing world, was met through this approval from the FDA.”

Kiran Mazumdar Shaw, Biocon

At the forefront of this trend is Kiran Mazumdar Shaw’s Biocon, which recently celebrated the US FDA approval of Ogivri™, the first biosimilar for trastuzumab and only the sixth approved biosimilar in the US overall. Although biopharmaceuticals are much costlier to develop than synthetic chemical drugs, Biocon has prioritized affordability and ensuring patients in both developed and developing markets can access its products.

As Mazumdar Shaw proudly notes, “[Ogivri™] was a drug that was approved in India in 2014 and I am very pleased that our strategic intent, which was to provide affordable access to patients in the developing world, was met through this approval from the FDA. In India we made a big difference because we expanded the market in terms of volume and brought down prices significantly. If you look at the discounted prices these products are sold at in India, they are a tenth of what they used to be elsewhere.”

Indeed, Mazumdar Shaw sees Biocon’s business model as a counterpoint to those traditionally seen in developed markets, positing that “The Western model has been about low volume – high value, whereas we believe in the opposite.”

She continues, “India is very new to biologic treatments and we want to change the paradigm of treatment for conditions such as cancer and autoimmune diseases.” This role as a frontrunner in Indian biopharma is not lost on Mazumdar Shaw, who points out that “As a company we have focused very much on taking a path of differentiation, which is doubtless a path full of challenges and risks because biosimilars require deep pockets and taking regulatory risks that are unknown – but we decided to go for it.”

Mazumdar Shaw is keen to stress that Biocon’s high-volume – low-value approach is not being pursued at the expense of quality. Indeed, she explains that through the recent FDA approval for Ogivri™, Biocon is bucking the ‘low quality’ stereotype often attached to Indian companies. “Our mantra is ‘highest quality at lowest cost’ and in order to prove that, you have to have accreditation from top-notch regulatory agencies.

US FDA approval is the crowning glory for any company aspiring to play in this business. Getting the approval for Ogivri™ is a great endorsement of the quality of this product and of our ability to develop these complex drugs for global markets,” she articulates. Biocon has also had products approved in other developed markets with strict regulatory agencies, with Mazumdar Shaw explaining that “Japan is also a very highly regulated market, but we managed to get our insulin, glargine, approved by the PMDA [the Japanese regulatory agency]. This was a big milestone for us.”

Another Indian firm, Zydus Cadila, is also making its mark in global biosimilars, with chairman and managing director, Pankaj Patel, explaining that “Biosimilars are at the core of our business and we started working on them in the early 2000s.” Notable successes include the 2014 launch of the biosimilar of Adalimumab, used for the treatment of auto-immune disorders, at one fifth of the price of the innovator drug – AbbVie’s Humira – in India.

Building on this local success, Patel is now keen to expand the company’s low-cost biological products to patients in other emerging markets that would struggle to afford originator drugs. “As far as the domestic market is concerned, we have been quite successful as we have developed and commercialized nine products. Our global strategy is now to out-license to large local companies in emerging markets such as Russia, Brazil and Colombia,” he expounds. “Biosimilars are very interesting as access is very poor and prices are mostly high in many markets around the world. Our mission is to enhance access and bring them at an affordable price,” Patel concludes.

For Wockhardt, the company’s efforts in biotechnology have led to the successful launch of the products Wepox (recombinant human erythropoietin), Wosulin (recombinant human insulin) and Glaritus (long-acting Insulin Glargine) in India and other emerging markets. Murtaza Khorakiwala, Wockhardt’s managing director in India, highlights the fact that the prohibitive cost of biotechnology research and development wards off many of the company’s competitors from entering the biosimilars field.

He posits that “We have acquired biosimilars as we have the molecules and not so many companies are willing to invest in them. At the end of the day, it is a high-risk high-returns view as companies have a lot of operations to carry out in order to stay competitive.” Noting the potential benefits of biosimilar investment however, Khorakiwala continues, “Imagine if there are 20 companies in the generics space, and five of them are willing to invest in the biosimilar space. Every molecule is unique, so you are unlikely to have many companies with the same model.”

Raymond De Vré, senior vice president and head of business operations and strategy for biologics at Dr. Reddy’s, describes his organization’s biosimilars portfolio as “an important element of Dr. Reddy’s ongoing transition into a specialty pharma company. Dr. Reddy’s is known as a pioneer and leader in quality generics, but our aspiration is to become much more than that in the future.” With a biosimilars footprint dating back to 2001, De Vré feels that Dr. Reddy’s is now able to supply biologics to the world’s most rigorously regulated markets, noting that “We currently have three products in clinical development for highly regulated markets. The first time we approached the US FDA was back in 2011 and we have learned a great deal in the intervening period with regards to our ability to fully design and execute an end-to-end high quality biosimilar program. We believe that we are one of the few companies with this kind of program outside of the US and Europe.”

Writer: Patrick Burton