Lupin is aiming for a bigger thrust on the USD 54-billion complex generics market as it tries to insulate itself from increasing competition and consolidation of distribution channel in US in plain vanilla copycat drugs.
Out of USD 98-billion products under development 55 percent will come from complex categories like biosimilars, inhalation, depot injectables, opthalmic and topical dermatological drugs, the company said in its presentation at JP Morgan Healthcare conference in San Francisco, US.
Lupin—India’s number two company by sales—is banking on the inhalation pipeline worth USD 17 billion in the next three years. It said it is in discussions with the US FDA to explore opportunities to accelerate development timeline for inhalation programs.
The company has filed for Albuterol metered dose inhaler (MDI) and Budesonide suspension and is awaiting US FDA approval, and is planning to file dry powder inhaler (DPI)-1.
Lupin said it expects high single-digit price erosion in generic drugs in the US to continue in 2018.
On biosimilars, the company said it is targeting to file Etanercept (Enbrel) in first quarter of FY19 in Europe and third quarter of FY20 in US.
Etanercept is the biosimilar version of US-based Amgen Inc.’s drug Enbrel with global sales of USD 6 billion in 2016. It is used to treat five chronic inflammatory conditions, including rheumatoid arthritis and plaque psoriasis.
Lupin also said its Ranibizumab biosimilar is phase 1 while Pegfilgrastim, Dilgrastim, Denosumab, Petuzumab and Afliberept are in early stages of development.
The company said it has received IND approval from US FDA to initiate pivotal trials on humans.
Lupin said it expects the pricing pressure to be in high single digits in 2018 on account of customer consolidation and increased competition.
The top three distributors now account for 90 percent of generic drugs purchases giving them significant bargaining power.
Government initiatives to reduce healthcare costs and rise in competition in generic drugs are also seen putting pressure on pricing, the company said.
Lupin said competition intensified as 47 new generic drug manufacturers entered the US market in 2017 and regulatory approvals for generic drugs have also increased.
"(US)FDA approving more abbreviated new drug applications (ANDAs) but fewer approvals for new generics," Lupin said.
US FDA approved a record 763 generic drugs in the US fiscal year ended September 2017, as against 651 in the previous year.
Lupin earlier said its complex generic portfolio is likely to start contributing to its earnings growth from fiscal year 2019-20 and until then, the company’s growth is likely to hinge on the quantum of generic drug approvals in the US and its efforts to improve operational efficiencies.
The company has been grappling with regulatory woes after its two plants in Goa and Indore in November got warning letters from US FDA for deviation in good manufacturing practices that could further delay product approvals in the US from those units and hinder growth.
The company said it is focusing on resolution of warning letters at the moment.