Biocon Biologics, the subsidiary of Biocon that manufactures and distributes biosimilar and other biologic drugs globally expects its two key biosmilars Fulphila and Ogivri to gain double-digit market share in the U.S., the world's largest market for such drugs by value.
Shreehas Tambe, deputy CEO, Biocon Biologics, told Moneycontrol in an interview that the company expects more patient footfalls in US hospitals in coming months which will help its two key biosimilars Fulphila and Ogvri improve market share.
In addition Tambe said he expects growth to be fuelled by regulatory approvals of biosimilar Bevacizumab and biosimilar Aspart in the near-term.
He said the company was not ready for IPO yet, as there are some regulatory approval and growth triggers which are lined up ahead. Tambe added that Biocon Biologics may determine the timing over the next couple of years.
Edited excerpts:
Has the 10 percent revenue growth of Biocon Biologics in Q1FY22 largely been driven by COVID-related sales in India and emerging markets?
Biocon Biologics reported revenue of Rs 758 Crore, representing YoY growth of 10 percent and QoQ growth of 14 percent. While our Q1FY22 revenues were boosted by a strong performance of our Branded Formulations business in India, which also includes the COVID-19 portfolio, we also witnessed steady growth of our global biosimilars business in key emerging and developed markets.
Due to the severe second wave of the COVID-19 pandemic in India, we saw a significant contribution of our COVID-19 portfolio, predominantly Itolizumab and Remdesivir, in offering treatment to patients. Thus far, more than 50,000 patients have benefited from these products. Our non-COVID portfolio in India has also performed well.
As sales of our biosimilars in emerging markets picked up this quarter, we also continued to maintain and garner market share for our commercialized products in the US. Our sales in Europe continued to improve on the back of new market entries and sustained market share of key biosimilars in some of the countries.
You said the U.S. market is seeing an increase in competitive intensity, and the ramp-up has been gradual - what is the situation in that market? When do we expect highly regulated markets such as the US and Europe to start firing?
We have steady sales coming in from the US and EU markets. Our biosimilars continued to maintain and garner market share in the U.S. Whilst Fulphila, our biosimilar Pegfilgrastim, maintained over a steady market share of around 8.5 percent; Ogivri, our biosimilar Trastuzumab, registered over 9 percent volume share in June 2021; and our biosimilar Insulin Glargine, Semglee, was estimated to be around 2.6 percent, about 20 bps higher month-on-month. We anticipate continued pricing pressure in the U.S. and are taking steps to mitigate this through increased volumes and market share.
We have been able to hold on to our U.S. market share for Trastuzumab and Pegfilgrastim despite the fact that the pandemic led to a reduction in hospital visits and diagnoses, leading to lower consumption of cancer therapies. With the US coming out of the pandemic, we are starting to see more patient footfalls in hospitals. Going ahead, we see an opportunity for Fulphila to improve market share. For Ogivri, too, we believe growth prospects remain strong. We thus expect market shares for these two biosimilars to ramp up to double-digits.
In addition to this, we expect our growth to be fuelled by regulatory approvals of biosimilar Bevacizumab and biosimilar Aspart in the near-term.
Going forward, we believe bBevacizumab will present a sizable opportunity for us in the U.S. market, once approved. We see a long-term play for us in the oncology space in the U.S. with a complete offering in terms of Pegfilgrastim, Trastuzumab and then Bevacizumab.
In Europe, our sales continue to improve on the back of new market entries and better market share in key countries. We have obtained regulatory approvals for key biosimilars of Bevacizumab and Insulin Aspart, making us the select few globally to have five biosimilars approved in Europe. The EU launch of biosimilar Bevacizumab by Viatris is expected in Germany, Austria, and Poland in Q2 FY22.
The U.S. FDA approval of biosimilar Bevacizumab has been stuck for some time due to pending pre-approval inspection. What is the status, are you in touch with US FDA?
It is unfortunate that due to the ongoing pandemic and travel restrictions related to this, U.S. FDA officials have not been able to travel to India. Hence, the pre-approval inspection of our facility has been delayed. We are awaiting the timing of the site inspection. However, please note that there are no additional data requests from the agency related to the Bevacizumab application.
What is the status of interchangeability application of Insulin Glargine, any communication from USFDA on target action date (TAD)?
We expect the U.S. FDA’s decision on interchangeability of our biosimilar Glargine by the end of this month.
What is the progress of Insulin Aspart and its TAD? Do these need U.S. FDA inspections?
The U.S. FDA had initially set July 2021 as the goal date for the bAspart BLA. The agency has now scheduled a pre-approval inspection of our bAspart manufacturing facility in Malaysia by the end of Q3 of calendar year 2021. There are currently no pending technical or clinical queries on the biosimilar Aspart BLA submitted to the U.S. FDA.
What is the status of Capex plans for the biologics division?
We have completed the qualification process for the first phase of our new monoclonal antibodies (mAbs) Drug Substance (B3) facility in Biocon Park. At 350,000-sq. ft., this is one of the largest mAbs manufacturing facilities in India in terms of the built-up area of a single building/site. Built at an investment of ~USD 120 million, this is India’s first biopharma facility awarded by the International Society for Pharmaceutical Engineering (ISPE) and is on track for commercialization in FY22. When completed the B3 facility would boost our mAbs production capacity substantially.
We also completed qualification of our first single-use mAbs facility (B5) in Bengaluru. Scale-up and manufacturing of our pipeline molecules is ongoing at this 150,000 sq. ft. facility. Both B3 and B5 facilities will support our future growth and drug development pipeline.
Our capital expenditure in FY21 was ~USD 125 million, net of partner funding, primarily for the expansion of our production capacity for mAbs. In FY22, we are looking at an additional capital expenditure of about USD 100 million.
Any update on your development of the pipeline of next generation biosimilars?
We continue to invest in the development of our next wave of biosimilar molecules, which we expect to commercialize over the second half of this decade. We are making good progress in terms of the CMC aspect of the development of some of these assets, advancing them towards the clinical development stage.
Any plans on the IPO of Biocon Biologics?
The $330 million raised from marquee funds such as True North, Tata Capital Growth, Goldman Sachs, and the Abu Dhabi-based ADQ so far takes care of our near-term capital requirements allowing us to be flexible with our IPO timelines. There are some regulatory approval and growth triggers which are lined up ahead of us. We believe these are important events for driving our valuation and then determine the time of IPO over the next couple of years.
What is this collaboration with Adagio?
Biocon Biologics has partnered with U.S.-based Adagio Therapeutics for an exclusive license to manufacture and commercialize a novel antibody for the prevention and treatment of COVID-19, for India and select emerging markets. With its potential to address resistant variants, including the Delta variant, and its ability to be administered easily as a single, intramuscular injection in the outpatient setting, ADG20 is uniquely poised to address the current need for an effective, safe and convenient therapy for COVID-19. Initial data indicate that ADG20, Adagio’s lead clinical development candidate, could provide both rapid and durable protection against COVID-19 for up to one year. This could make it an ideal agent to prevent infections and significantly reduce COVID-19 related hospitalizations and death.
When will the therapy be available to patients?
Adagio has published preliminary data from its ongoing Phase 1 trial in healthy volunteers, which support ADG20’s safety and pharmacokinetic profile and SARS-CoV-2 neutralizing activity. It is currently conducting two global Phase 2/3 clinical trials with ADG 20, which will support an Emergency Use Authorization (EUA) submission in the U.S.
Adagio plans to seek EUA in the U.S. as early as the first quarter of 2022. Under the terms of the deal, Biocon Biologics will get access to the clinical and non-clinical data from Adagio’s EUA submission to the U.S.FDA to seek approvals in the emerging markets.