“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,” said Vinita Gupta, CEO and Nilesh Gupta, MD of Lupin in the company’s annual report.
Lupin, India’s third-largest drugmaker said it will be focusing on execution of complex generics pipeline, biosimilars and speciality portfolio to improve profitability, even as it tries to overcome pricing pressure and regulatory challenges in the key US market.
The company is spending little over $200 million annually on research and development, much of it targeting inhalation, biosimilars and speciality drugs.
Lupin is the third-largest drugmaker by prescriptions, behind Teva and Aurobindo Pharma in the US market.
But the sales in that market have been on decline primarily due to the generics competition to its speciality product Methergine used in the treatment of postpartum bleeding, coupled with the loss of exclusivity on two of metformin products Glumetza and Fortamet.
The US sales in FY19 dropped 12 percent to $777 million compared to the previous year.
“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,” said Vinita Gupta, CEO and Nilesh Gupta, MD of Lupin in the company’s annual report.
Lupin’s biosimilar Etanercept indicated for treating certain autoimmune diseases is already approved in Japan and is filed in Europe.
EU authorities completed the inspection of Lupin's manufacturing facility in Pune that makes Etanercept. The company expects EU approval in FY20.
“Etanercept is expected to be launched in both Japan as well as in Europe in the second half of FY2020,” Lupin said.
The company also said the bridging and interchangeability studies for Etanercept filing in the US is progressing. Meanwhile, Lupin had partnered with Mylan and Nichi-Iko for commercializing biosimilars Etanercept in certain ex-US markets. Etanercept sold by US biotech major Amgen under brand name Enbrel had global sales of $9.5 billion for the year ended March, as per IQVIA. Lupin had spent over $100 million on developing Etanercept for global markets.
Lupin is also banking on its speciality products such as Solosec in the US, NaMuscla in Europe and Bipresso in Japan will help us drive sustainable growth.
Solosec is an antimicrobial agent against bacterial vaginosis (BV), NaMuscla to treat a rare neuromuscular disorder and Bipresso meant for bipolar depression.
On inhalation front Lupin, the company said it had filed three major inhalation products generic ProAir, Spiriva and Brovana in the US, with collective US sales of almost $5 billion. The company has a first-to-file (FTF) status for Spiriva or Tiotropium DPI in the US. FTF makes the company eligible for 180-day marketing exclusivity.
Lupin has 157 abbreviated new drug applications (ANDAs) pending approval with the USFDA for approval, of which have 40 are first-to-file opportunities addressing a market size of $30.6 billion.
Lupin’s ability to executive will depend on the resolution of regulatory compliance issues at four of its plants in Goa, Pithampur, Mandideep and Somerset. New approvals from all the four units are blocked by USFDA, constraining company’s efforts to turn around its US business.
Goa and Pithampur Unit -2 have warning letters and Mandideep and Somerset in US inspections are classified for official action indicated (OAI).
