NEW DELHI, July 14: Drug maker Lupin aims to launch its first biosimilar product and commercialise its first inhalation product in the US in the current fiscal.
Addressing shareholders in the company’s Annual Report for 2018-19, Lupin Chief Executive Officer Vinita Gupta and Managing Director Nilesh Gupta said the new launches across the globe would help it achieve sustainable growth.
“Looking ahead, FY2020 is an exciting year for Lupin as we plan to bring our first biosimilar to market, commercialise our first inhalation product in the US, continue the growth momentum in our US generics business and launch our injectables portfolio,” they said in a joint letter to the shareholders.
Coupling this with the building of Solosec brand in the US, NaMuscla in Europe and Bipresso in Japan will help the company drive sustainable growth, they added.
“Creating a growth business while making a difference, has been our ambition. We are committed to building a promising future. We will deliver this by executing on our well-defined strategic priorities, investing in capabilities and manufacturing excellence to support operations that meet the highest standards,” the company’s leadership said.
The firm’s first biosimilar Etanercept is approved for launch in Japan, while the European approval is awaited, the report said.
Lupin said it launched 22 new products in the US market last fiscal.
“With over 157 abbreviated new drug applications (ANDAs) currently pending approval with the USFDA, we have a rich pipeline addressing a total market size of over USD 52 billion,” the letter said.
Lupin added that while there were many successes throughout the course of the last financial year, the company also faced many challenges on the compliance front.
“We had our share of challenges, particularly, on the compliance front. We have made significant progress on our remediation and enhancement plan and are committed to sustainable compliance throughout all our sites. As an organisation this is one of our biggest priorities,” the letter said.
The Mumbai-based company’s various manufacturing plants have come under the US Food and Drug Adminstration’s (USFDA) scanner for various compliance issues. (PTI)