Biosimilars

Lupin gets US FDA nod for its first biosimilar drug Pegfilgrastim

The product, a biosimilar to Amgen's popular drug Neulasta, will be manufactured at Lupin's biotech facility in Pune

USFDA's new biosimilar norms to woo more players, fast-track mkt entry

Indian cos like Biocon, DRL, Intas, Lupin stand to benefit from the proposed move

Biocon inks settlement, license pact with Amgen to market biosimilars in US

Biotechnology firm Biocon on Wednesday said its unit has inked a settlement and license agreement with Amgen Inc., paving the way for commercialisation of two biosimilars used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics has inked the pact with Amgen Inc for the commercialisation of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the US, the company said in a regulatory filing. Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial are biosimilars to Amgen's Prolia and Xgeva, respectively. These products are used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the US District Court for the District of New Jersey, the Bengaluru-based firm said. The agreement enables Biocon Biologics to launch Bosaya and Aukels

Dr Reddy's, Alvotech to co-develop biosimilar of cancer drug Keytruda

The partnership marks a strategic boost to Dr Reddy's oncology portfolio and expands Alvotech's biosimilar pipeline as Keytruda patents near expiry

Will launch 3 biosimilars globally in 2-3 years: Biocon Biologics CEO & MD

Shreehas Tambe, MD & CEO, Biocon Biologics talks about refinancing, upcoming launches, and future roadmap, in a virtual interaction

Biocon Biologics completes integration of Viatris' biosimilars business

Biocon Biologics bought Viatris' global biosimilars business last year to become one of the top five global players in the space

Cipla's Gulf arm to sell 4 biosimilar medicines in Australia, New Zealand

Cipla stock went up by almost 3 per cent on Tuesday

Biocon Biologics inks pact to expand access to its cancer biosimilars

Biocon Biologics is an arm of biotechnology major Biocon

Market reacts negatively to Biocon's weaker results, exit of biologics' MD

Analysts have raised doubts over the $1 billion guidance for biosimilars by FY22 and Hamacher's exit due to "professional differences"

Multiple growth levers for Biocon; ramp-up, new biosimilars to boost profit

Ramp-up and new biosimilars should help boost profit

US to lead Biocon Biologics' drive towards $1 billion revenue

The company is uniquely positioned in the US as it is the only Indian pharmaceutical firm with two commercialised biosimilars in the market

Biosimilar market on the growth path as top drugs double in size

Data shows while the overall biosimilars category has clocked a 10.3% value compound annual growth rate (CAGR) over the past few years, the market size for the top molecule has more than doubled

Our aim is to be a global leader in biosimilars biz: Biocon Biologics CEO

Margins of biologics stood at 38% in Q1 as compared to 33% in the preceding quarter

Indian biosimilar market likely to touch $1 billion in three years

The demand for biosimilars is bound to increase with more complex biologics going off-patent

Indian biosimilars market may reach $40 billion by 2030: Assocham report

The biosimilars opportunity is nascent today and the 2016 estimated market size was only $2.2 billion