The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June. While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval. This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022. Alvotech plans to resubmit ...
More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
CDMO company Cambrex completed the second phase of an expansion at its Snapdragon Chemistry API production facility in Waltham, Massachusetts.The project added 51,000 square feet to the facility’s footprint, the company said in a May 16 press release. Among the new features at the plant are process R&D labs with 100-liter and 60-liter glass-lined steel reactors plus a 10-liter plug flow reactor, the company said. Cambrex didn’t reveal its total investment in the project. The company expects the new suites to be operating in June. “The capabilities and capacity added in Waltham are designed to support the industry’s most complex chemical development needs, consistent with Snapdragon’s expertise and history,” Tom Loewald, Cambrex chief executive, said in the release. Cambrex acquired Snapdragon for an undisclosed sum in November as part of its strategy to expand API offerings. With the deal, Cambrex picked up two Snapdragon facilities in Waltham. Prior to the ...
The copycat version of AbbVie’s blockbuster still has court clearance to launch on July 1, but only if regulators have approved it. For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday. The agency’s decision comes less than three months before Alvotech is free to launch the drug in the U.S. under a settlement with AbbVie, Humira’s manufacturer. Alvotech has a second FDA application pending that, if approved by June 28, would make it one of the first “interchangeable” Humira biosimilars, meaning pharmacists could directly substitute it for the branded product. An expected launch on July 1 could be delayed if the FDA doesn’t grant the main approval, which would clear the biosimilar for sale in the U.S. In a statement Thursday evening, Alvotech said it provided ...
Cassipa, a Teva Phaarmaceuticals manufactured sublingual film containing naloxone and buprenorphine in new dosage amounts, receives FDA approval on the 7th of September as a continuing therapy for opioid addiction. In a press release, the FDA announced that the buprenorphine and naloxone sublingual film, formulated in a 16 mg/4 mg dose for Cassipa, is sanctioned not only in its brand version but also in its generic edition. The two drugs in different strength combinations are also approved by the FDA. A set management protocol including psychotherapy and counseling should comprise of Cassipa post the patient is administered and stabilized with a step-ladder buprenorphine 16 mg dose of another brand. Drug Addiction Treatment Act (DATA) certified professionals only can prescribe these drugs. “There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder … the FDA recently described a streamlined approach to ...
Xolair of Novartis and Roche has been declared as a breakthrough therapy for food allergies including eggs, milk and peanuts by the Food and Drugs Administration (FDA).
At the beginning of this month, the U.S. Food and Drug Administration (FDA) announced to withdraw drugs containing valsartan, which treat high blood pressure and heart failure. The drugs were withdrawn due to the presence of N-nitrosodimethylamine (NDMA), which might lead to cancer.
Nucala (mepolizumab) was first approved as the first anti-IL5 treatment for adults and adolescents with severe asthma accompanied by eosinophilic phenotype in the United States during November 2015. Later it was approved to treat eosinophilic granulomatosis with polyangiitis (EGPA).
Scott Gottlieb, FDA Commissioner is looking for help from Facebook and Twitter to slow down the unauthorized opioid sales in the US. Gottlieb invited the two social media giants, among others, to participate in the FDA Online Opioid Summit which is set for June 27.
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