‘We are still without peers in biosimilars’

March 10, 2021 3:30 AM

We have invested in multiple manufacturing techniques and technologies to improve our productivity. The enhanced use of digital and automation technology has reduced the need for manual intervention and led to faster turn-around times.

We will re-assess the timeline for accomplishing that target when normality is restored in the post-Covid era.We will re-assess the timeline for accomplishing that target when normality is restored in the post-Covid era.

By Srinath Srinivasan

Biocon clocked 10% revenue growth in the Covid-hit M9FY21. In an interview with FE’s Srinath Srinivasan, Kiran Mazumdar Shaw, executive chairperson, highlights the reasons for her confidence in the biosimilar business. Edited excerpts:

How has the pandemic changed the way Biocon and its subsidiaries operate? Could you outline the last 9 months of 2020 at your company?
The year 2020 was one of the most challenging years humanity has ever faced. Covid-19 impacted our businesses too. Despite the challenges, Biocon’s revenues grew by 10% to `5,323 crore in the first nine months of FY21, being driven by 14% growth in our Biosimilars business, 9% rise in Research Services revenue and 7% higher revenue in the generics segment. We also delivered on our “patients first” promise across our businesses. An effective business continuity plan allowed us to run essential and critical manufacturing and quality operations with reduced staffing.

At the same time, we prioritised the health and safety of our employees and also contributed to the global efforts to tackle Covid-19 through innovative science. Biocon Biologics repurposed its psoriasis drug ALZUMAb (Itolizumab), an anti-CD-6 IgG1 monoclonal antibody, to treat Covid-19 complications. Besides ALZUMAb, we were able to offer a portfolio of therapies involving Cytosorb, Araflu and RemWin, which work for Covid-19 patients at different stages of infection. Syngene used its scientific expertise and resources to join hands in the fight against the coronavirus. It developed an RT-PCR diagnostic platform and made available one of its high-end labs to help the government scale up testing in Karnataka. It also set up a new RT-PCR testing facility.

While the USFDA deferring its decision on the Avastin biosimilar has affected the Biocon stock’s performance, the launch of Tacrolimus capsules was received well by the market. How do you view these developments?
The USA is a key market for Biocon’s Generic Formulations and Biosimilars businesses. We have three Generic Formulations – Rosuvastatin, Simvastatin and Atorvastatin – commercialised under our label in the US, which enjoy a mid-to high-teens market share. We have also expanded our portfolio of complex products for the US market with the launch of Tacrolimus capsules. In Biosimilars, Biocon Biologics is the only company from India to have a biosimilar monoclonal antibody (Trastuzumab), a therapeutic protein (Pegfilgrastim) and an insulin analog (Glargine) commercialised in the US. We continue to believe the US market will be one of the biggest drivers of revenue growth for Biocon.

Your partner Equillium did not initiate Phase-3 trials for Itolizumab in the US after assessing its efficacy in the treatment of Covid-19. What is the current status of the drug?
As disclosed earlier, our partner Equillium made the strategic decision not to initiate Phase 3 trials for Itolizumab on Covid-19 patients, as planned earlier, owing to the development of vaccines and other efficacious treatment options. Instead, our partner has decided to expand and accelerate its clinical programme for acute graft-versus-host disease (aGVHD), as well as advance the company’s lupus/lupus nephritis and uncontrolled asthma studies using Itolizumab.

What progress have you made on Semglee (Insulin Glargine) and Ogivri (Trastuzumab) since their commercialisation in the US/EU markets? Is the biologics business on track to reach the revenue target of $1 billion by FY22?
The biosimilars business reported a strong financial performance in the Oct-Dec quarter of FY21, on the back of a greater supply of Insulin Glargine to the US market and a modest increase in the market share of bTrastuzumab and bPegfilgrastim in that market. While we have seen healthy growth in business over the last few quarters, the impact of Covid-19 across the value chain has not allowed us to meet our expectations, dampening the prospects of the $1-bn revenue target being reached by FY22. We will re-assess the timeline for accomplishing that target when normality is restored in the post-Covid era.

What key changes did you introduce at your manufacturing facilities during the pandemic? How are your manufacturing expansion and digitalisation plans shaping up?
We have invested in multiple manufacturing techniques and technologies to improve our productivity. The enhanced use of digital and automation technology has reduced the need for manual intervention and led to faster turn-around times. We are leveraging digital technologies in our manufacturing and supply chain to gain real-time control, all the way from procurement to the patients. The use of new digital tools will help increase overall compliance and efficiencies.

What is your outlook on the year ahead?
Notwithstanding the uncertainties and the challenging business environment, we have done well on a quarter-to-quarter basis, with our consolidated performance in the Oct-Dec quarter being driven by Research Services and Biosimilars. We are confident that the fundamentals of our business, as also the biosimilar market, remain sound and we remain committed to delivering on the long-term growth potential.

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