Biocon biosimilar captures 21% of US Neulasta market, eyes capacity boost

Biocon says it is making a “very significant expansion” in its manufacturing capacity to feed the demand for biosimilars, including its pegfilgrastim product Fulphila.

In June 2018, Fulphila became the first biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim) to win US Food and Drug Administration (FDA) approval.

The biosimilar is marketed in the region by Mylan but manufactured by partner Biocon. In its Q1 FY2020 results, the Indian drugmaker claimed Fulphila captured a 21% volume share of the US pegfilgrastim syringes market.

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During a call to discuss results, a company representative described the arrival of Fulphila in the US as a success, with further impact to come. And to penetrate the market further, the firm said it will create more capacity to meet the increased demand for both Fulphila and its other biosimilars.

“Our investment strategy for manufacturing has been to build capacity in a modular manner in line with our projections of the market opportunity,” chair and managing director Kiran Mazumdar-Shaw told stakeholders.

“This has allowed us to scale up capacity in response to higher-than-expected demand, even as we balance exposure to any underutilized capacity and cost in the early phase.”

She added the firm “will continue to invest in expanding [its] manufacturing capacities to address volume growth on account of increased penetration of [its] products in developed and emerging markets and also to support new biosimilar pipeline development and launches.”

2-3 times capacity

Biocon has already begun construction of a $200 million (€179 million) hybrid biomanufacturing plant at its site in Bangalore, India to produce monoclonal antibodies (mAbs).

“The new molecule antibodies facility in Bangalore is expected to be commissioned in FY ’20 followed by qualification and validation activities,” said Mazumdar-Shaw, with commercial operations expected to begin in late FY ’21 or early FY ’22.

However, the firm said it will “bring in more capacity towards the end of the second half of this year” to keep up with the strong demand for its products.

While the size of the expansions have not been divulged, Mazumdar-Shaw was asked if the plans would double or triple current production

“We see ourselves as being a global leader in biosimilars, so obviously, the capacity expansion is going to be along those kinds of aspirational linesSo we are putting in very significant expansion in our capacities.”

For the quarter, Biocon saw a 96% year-on-year jump in its biologics revenues to INR490 crore ($70 million).