Biocon’s Biosimilars Revenue Up 34% YoY

In Biocon’s second quarter of fiscal year 2023 (FY23) earnings report, revenues were up 23% year over year (YoY) for the company, largely in thanks to the 34% increase in revenues for biosimilars and accounting for 42% of the total company revenue.

Overall, the Bengaluru, India–based Biocon made Rs 2,384 Crore in consolidated revenue and biosimilars accumulated Rs 997 Crore, which was managed by Biocon Biologics, the biosimilars division of Biocon. Biocon spent Rs 252 Crore in research and development (R&D).

Additionally, generics and active pharmaceutical ingredients (APIs) accounted for 26% of the total Biocon revenue and were up 18% YoY, accumulating Rs 623 Crore in revenue. Research services accounted for 32% of the total revenue and garnered Rs 768 Crore in revenue, up 26% from the same quarter the previous fiscal year.

Earlier in 2022, Biocon Biologics announced that it would acquire Viatris’ entire biosimilar portfolio. Together, the companies developed Semglee (insulin glargine-yfgn), which became the first biosimilar to receive an interchangeability designation in the United States.

In the company’s statement, Biocon said that on the deal with Viatris closing, Biocon Biologics will issue payments valued at around $1 billion and upfront cash payments of $2 billion to Viatris, resulting in $1.2 billion in debt for Biocon Biologics so that it can fund the cash components of the deal. The balance is said to be funded through and equity infusion of $650 million by Biosim and $150 million by the Serum Institute Vaccine Alliance.

“The consolidation of Viatris’ global biosimilars business and the strategic vaccines alliance with Serum Institute will add to the growth of the Biosimilars business in H2FY23. We have secured necessary financing and obtained relevant approvals for the Viatris transaction, which is expected to close shortly,” said Kiran Mazumdar-Shaw, executive chairperson of Biocon and Biocon Biologics.

The company said that the revenue growth for Biocon Biologics was led by a “strong performance of its biosimilars portfolio in advanced and emerging markets.” Currently, the company has developed 7 biosimilars: a pegfilgrastim (Fulphila), a trastuzumab (Orgivri), a bevacizumab, an insulin glargine (Semglee), an insulin aspart, an adalimumab, and an etanercept.

Over the next few years, the company will add several vaccines, an aflibercept biosimilars, an ustekinumab biosimilar, a denosumab biosimilar, a pertuzumab biosimilar, and seven other undisclosed biosimilar molecule to its global pipeline. Both the ustekinumab and denosumab candidates are being assessed in global clinical trials.

The news follows the growth that was exhibited during the fourth quarter of the 2022 fiscal year, during which Biocon’s total revenue was up 21% from the same quarter the previous fiscal year, a feat that was largely attributed to the increased revenue from biosimilars and generics.

The uptake of Fulphila in the United States surpassed 10%, despite the introduction of more pegfilgrastim competitors and the continued success of the originator’s on-body injector (Neulasta Onpro).

Ogivri continued to be the leading trastuzumab product in the Canadian and Australian markets, generating over 30% market share in both countries. Additionally, Biocon and Viatris’ bevacizumab and trastuzumab biosimilars have been introduced in some European markets and their adalimumab biosimilar has continued to have strong uptake in Germany in France.

Biocon Biologics has signed a commercialization agreement with Yoshindo Inc for the commercialization of the ustekinumab and denosumab biosimilar candidates in Japan.

The company noted that the insulin glargine and aspart molecules hold double-digit market share in several countries, including Malaysia, Mexico, Argentina, and Brazil, and its monoclonal antibody biosimilars have won tender contracts in the African and Middle Eastern region.