Roche wins reprieve as Novartis biosimilar delayed in U.S.

 Roche has won a reprieve from an expected wave of cheaper versions of its biotech cancer drugs as U.S. regulators knocked back a biosimilar form of rituximab from Swiss rival Novartis.
Novartis's Sandoz unit said its copy of Roche blockbuster Rituxan -- used to treat blood cancers and certain immunological diseases -- had received a so-called complete response letter from the U.S. Food and Drug Administration (FDA).
The FDA issues such letters when it is not ready to approve a product.
The news follows a similar setback for another biosimilar copy of Rituxan from Celltrion and its partner Teva. Together, the two delays win Roche extra breathing space in the crucial U.S. market.
Roche shares rose nearly 2 percent by 0840 GMT while Novartis stock was little changed.
Deutsche Bank analyst Tim Race said Rituxan could now remain free from biosimilar competitors in the United States this year, with erosion threatening only from 2019.
Rituxan generates about $4 billion of U.S. sales for Roche.
Race said he had been expecting a sales loss to biosimilars of about $150 million in 2018 and and Roche earnings would be around 0.5 percent higher if this was removed.
For 2019 Race assumes a $1 billion fall in U.S. Rituxan sales versus 2017, so if biosimilars enter from mid-2019 there could be an earnings uplift of about 2 percent.
Sandoz said it was evaluating the FDA letter and it stood behind the "robust" evidence included in the regulatory submission for its biosimilar.
"While disappointed, Sandoz remains committed to further discussions with the FDA to bring this important medicine to U.S. patients as soon as possible," it said.
The problems facing Rituxan biosimilars in the United States are in sharp contrast to the situation in Europe, where copies of the drug from both Celltrion and Novartis are already available and uptake of the cut-price medicine is hurting Roche.
Rituxan sales plunged by 44 percent in Europe in the first quarter of 2018.
The tussles in the biosimilars market are a growing focus for investors, with soaring valuations for some pioneers in the field, such as South Korea's Celltrion, and worries about the long-term sales threat to makers of original drugs, such as Roche and AbbVie.
Overall, U.S. regulators have lagged behind Europe in approving biosimilars, while a complex system of rebates offered to insurers by original-brand drugmakers has also created barriers to use.
Biological drugs such as Rituxan are complex molecules made inside living cells, which means that rivals seeking to make copies when patents expire can only ever produce medicines that are similar to the original rather than identical.

Source:https://health.economictimes.indiatimes.com/news/pharma/roche-wins-reprieve-as-novartis-biosimilar-delayed-in-u-s-/64014141

Comments

Post a Comment

Popular posts from this blog

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R...
Read more

Tumour-targeting drug paves way for bone cancer treatment

 The treatment of osteosarcoma, the most common tumour of bone, is challenging, but a new study is offering hope to the patients with this disease. The study led by The University of  Texas MD Anderson Cancer Centre  found that a drug, known as bone metastasis-targeting peptidomimetic (BMTP-11), has potential as a new therapeutic strategy for this devastating illness. Results from the preclinical study looked at BMTP-11 alone and in combination with the chemotherapy agent gemcitabine. Although osteosarcoma is a relatively rare cancer, it is a leading disease-related cause of death in children and young adults ages 10 to 20. However, over the last 25 years, the five-year survival rate has remained unchanged, and the treatment options for these patients are few. In addition, the side effects of available treatment options often are significant and cumulative, and may cause other health problems and damage to major organs. "What's novel about this treatment is that...
Read more

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death...
Read more