Indian firm Biocon has seen great success in the US in recent years, with two biosimilar launches and a range of generic medicines now available on the American market.


In a recent interview with PharmaBoardroom, Biocon’s Commercial Head Global Generics & SVP Marketing Abhijit Zutshi outlined the company’s recipe for success in the highly competitive US generics market, which accounts for a full 60 percent of the global generics ecosystem and is expected to grow to a value of USD 86 billion by 2022.


We did not jump on the bandwagon; we did things differently by leveraging our in-house expertise and know-how

Abhijit Zutshi, Biocon


Zutshi is keen to point out that Biocon stands out from the pack of other Indian generics outfits making moves into the US market. In 2017, Indian companies made up a full 38 percent of Abbreviated New Drug Applications (ANDAs), whereby a company seeks authorisation from the US FDA for a generic copy of a previously approved drug.

“Most Indian generics and biosimilars companies entered the formulations and biosimilars business because of the competitive economics of manufacturing in India versus other parts of the world,” he notes. “We did not jump on the bandwagon; we did things differently by leveraging our in-house expertise and know-how.”

For Zutshi, the reasons for Biocon’s successes in the US can be split into three key areas: regulatory and quality compliance in its manufacturing processes, how Biocon’s vertical integration ensures supply chain stability, and the leveraging of a robust global portfolio to introduce the products best suited for the US market.


Compliance & Quality

“We have had a very good track record with different regulators worldwide,” boasts Zutshi. “Every year, we go through more through 40 external regulatory audits from the EMA (Europe), FDA (USA), ANVISA (Brazil), COFEPRIS (Mexico), and PMDA (Japan). Any time you walk into our facilities, everything is how it is supposed to be. Nowadays, companies do not receive advance notice or warnings of these inspections, so we are always prepared. What you see is what you get.”

He adds, “As our technology is complex and has been developed in-house, it requires close adherence to our quality management systems. This is something we want to keep close to us. We do also manufacture in the US but the costs in India are still more competitive compared to in the US or Europe. We are evolving constantly to keep up with the competition. For instance, we also use various analytical tools to anticipate any potential disruptions with our suppliers, right down to tertiary supplies. This is another example of the value-add we can deliver to our customers. We are looking at the long-term game here.”


Vertical Integration & Supply Chain Reliability

Zutshi is also at pains to clarify how Biocon’s organisation is allowing it to guarantee continuity of supply. “The question of continuity of supply has been a huge issue in the last few years because there has been a lot of supply chain disruption,” he states “Supply chain is a competitive advantage for Biocon because we have strong quality systems and vertical integration, which ensures reliable and effective control over our supply chain.”

“This supply chain reliability and continuity, coupled with our strong global portfolio, has really helped us build a strong Biocon brand in the US in a very short span of time,” opines Zutshi. “While our generics formulations business has only been present in the US for two years and we only have three products in the market at the moment, we already have between 15 to 18 percent market share. Our customers have given us overwhelmingly positive feedback. Some of our buyers have told us that if they knew the drugs they were buying had been made with Biocon APIs, they did not have to worry about any supply disruption. That is a huge endorsement for us.”


A Strong Global Portfolio & Strategic Selections

While Biocon boasts a wide-ranging global portfolio of generic medicines, the adoption of a highly selective portfolio for the US market has been a key tenet of the firm’s success there. As Zutshi explains, “In terms of portfolio selection within the US, we are looking at products vertically integrated within our global supply chain as well as complex either in terms of APIs or formulations.”

“We do not want a generics portfolio with hundreds of products, we want to have a selective portfolio. We are looking at complex injectables and complex peptides as well. In terms of therapeutic areas, we see huge opportunities in complex drugs with a strong patient base, for instance, in immuno-oncology, organ transplantation, diabetes, and cardiovascular diseases,” he adds.

On the topic of staying ahead of its competitors, Zutshi is relatively sanguine. “It would be naïve to say we can avoid competition but with a complex portfolio, competition is more limited. For instance, with our rosuvastatin, even though it was the 18th or 19th generic approved in the US, we still managed to gain 17-18 percent market share,” he concludes.