Covid provides larger opportunity to shape the biosimilar landscape

Biocon Biologics announced its Q4FY20 numbers recently. The ongoing Covid-19 crisis has impacted the business in a significant way.

By Srinath Srinivasan

Biocon Biologics announced its Q4FY20 numbers recently. The ongoing Covid-19 crisis has impacted the business in a significant way. Biocon Biologics CEO and MD Christiane Hamacher discusses with Srinath Srinivasan the company’s ways of adjusting to the situation and executing operations in the new normal. Edited excerpts:

Given the hit to the Biologics business in Q4, do you see this trend continuing?
Biocon Biologics segment reported a de-growth of 21% to Rs 357 crore in Q4FY20 primarily due to operational challenges related to Covid-19. Excluding the Covid-19 impact, Biologics sales for Q4FY20 reported a single-digit growth. The temporary setback came after robust performances in the first three quarters of FY20. We expect the biosimilars business to recover Q1FY21 onwards on the back of growth opportunities of our key biosimilars supplemented by the expected US launch of Insulin Glargine in mid-calendar year 2020.

Based on the performance in FY20, is Biocon Biologics still confident of meeting its target of $1 billion revenue in FY22?
Biocon Biologics has reported a strong revenue growth of 29% at Rs 1,951 crore for the full year FY20 on the back of excellent performance in three consecutive quarters. Going forward, we expect to maintain the upward trajectory by capitalising on the new global opportunities that will propel us to our FY22 target.

The recent commercialisation of Fulphila (biosimilar Pegfilgrastim) in Canada and Australia adds to our oncology portfolio with Trastuzumab in both countries. We expect sales of biosimilar Pegfilgrastim and Trastuzumab to pick up in the US. Moreover, several positive developments during FY20 have kept us on track for the launch of Semglee (Glargine) in mid-calendar year 2020.

Glargine is a $2.2-billion market in the US and we believe this product will be an important contributor to our growth in FY21 and beyond. We further expect Pegfilgrastim and Trastuzumab sales to gain traction in many markets across Europe.

As our biosimilars start making inroads in most of the developed markets and with continued growth in most of the world markets, we are confident of crossing $1 billion in revenues and reaching 5 million patients annually in FY22.

WHO has said Covid may never go away. In such a scenario, how do you see this as a temporary setback?
We are expecting the business to recover from Q1FY21 onwards. From the longer-term perspective, Covid has given us an even larger opportunity to shape the biosimilar landscape. Global healthcare will be compelled to leverage both generics and biosimilars to contain healthcare costs and we would like to position ourselves in a leadership league that drives our vision of delivering affordable access to innovative and inclusive healthcare solutions.

The total global market of all biosimilar monoclonal antibodies and therapeutic proteins is anticipated to grow from ~ $25 billion today to $55 billion in 2025, based on consensus estimates. Our scientific expertise in developing and manufacturing complex biosimilars together with our partner’s commercialisation strengths position us well to be a global leader in the biosimilars space over the long term.

Do you have enough production capacity to cater to global demand for your biosimilars products?
We always dovetail capacity to our market plans and ensure that capacities come online to cater to increased market share or to anticipated regulatory approvals in various jurisdictions. While we have adequate capacity to cater to our near term needs, we have triggered expansions of existing facilities and new greenfield constructions to support future demand for our biosimilars. During FY20, we received the US FDA’s approval for enhanced manufacturing capacity for two of our key biosimilar products, Trastuzumab and Pegfilgrastim. These approvals will enable us to scale up capacity multi-fold and address the growing market opportunities in the US and other global markets.

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