Adalimumab-AFZB

Dive Brief:The Food and Drug Administration is reviewing Alvotechs newest application for its Humira biosimilar, setting a Feb. 24 deadline to decide on approval, the company said Wednesday. The regulator has twice rejected the drug because of manufacturing issues at an Iceland plant.Alvotech said its latest approval application contains additional information on the methods used to measure quality and consistency at that plant to address manufacturing facility deficiencies identified earlier by the FDA.If the decision is positive, the Iceland-based drugmaker will be more than a year behind the first U.S. Humira biosimilar launched by Amgen and seven months behind a wave that hit the market at mid-year. Alvotech had been banking on its product being one of the first interchangeable Humira biosimilars meaning it can be substituted by pharmacists although that advantage could diminish by the time it launches.Dive Insight:The expiration of AbbVies key patents on Humira earlier this year has led to a rush of biosimilar makers hoping to grab a share of the $18.6 billion in U.S. sales it recorded last year. Alvotech, which is partnered with generics giant Teva, was in the running for a slice of that revenue until regulatory hurdles got in the way, exacerbated by the FDAs inability to complete plant inspections during the COVID-19 pandemic.The initial setback came a year ago, when the FDA first identified manufacturing deficiencies. At the time, Alvotech said it intended to resolve the problems by December 2022, by which time a separate approval application seeking interchangeability was supposed to have a verdict from the FDA.In April, the FDA again rejected Alvotech's main approval application, based on deficiencies it spotted during a March inspection. And for good measure, it also knocked down the company's second attempt at an interchangeability approval just before it had the legal right to launch its biosimilar on July 1.Missing out on that revenue stream meant Alvotech needed to raise money. It would go on to bring in $140 million from Teva and other investors and other investors while also stepping up its involvement in getting the Iceland plant FDA-compliant.Alvotech is leaning heavily on its possible status as the only high-concentration interchangeable Humira biosimilar. Boehringer has won interchangeability status for its low-concentration drug named Cyltezo and Pfizer could earn the same status for its low-concentration biosimilar, called Abrilada, by the end of the year.In the meantime, big pharmacy benefit managers have already made deals with other biosimilar makers, increasing Alvotechs entry challenges. Cigna Healthcares Express Scripts and United Healthcares Optum have chosen Cyltezo, Amgens Amjevita and Novartis Hyrimoz, along with an unbranded Novartis biosimilar.CVS Health, meanwhile, has chosen a private label version of Hyrimoz and has also announced its intention to become more deeply involved in biosimilar commercialization. '

Samsung Biologics has expanded two biosimilar manufacturing deals with Pfizer to a total of $897 million. One of the deals, for $704 million, is the largest contract ever for the 12-year-old South Korean CDMO. With Pfizer set this month to launch its biosimilar version of AbbVie’s mega-blockbuster Humira, the company has expanded its partnership with Samsung Biologics, which will produce biosimilars for the pharma giant at its sprawling complex in South Korea. Samsung said on Monday that Pfizer had added $486 million to two biosimilar production agreements the companies had made earlier this year. Pfizer acknowledged the “strategic partnership” for the company’s “multi-product biosimilars portfolio,” but provided no further comment. Last month, Pfizer and Samsung signed a contract for the CDMO to produce biosimilar drugs in the fields of immunology, oncology and inflammation. And in March, the companies hooked up on a deal of $193 million, according to a regulatory filing. The June agreement, now worth $704 million, is the largest single contract Samsung Biologics has signed, the 12-year-old company said, topping a previous high of $360 million in a deal with AstraZeneca. The Pfizer contracts run through 2029. Samsung’s contracts signed this year add up to $1.48 billion, already exceeding the business the rapidly growing company executed last year. Work for Pfizer will be conducted in Samsung’s Plant 4 in Incheon, which was due for completion last month, the company said. Earlier this year, the company said it was starting construction on its $1.46 billion Plant 5, the first of four manufacturing buildings at its Bio Campus II. Other deals Samsung has made this year with Big Pharma players include a $177 million pact with Eli Lilly in March, a $27 million agreement with GSK in February and an $11 million commitment with Roche in June. For its part, Pfizer is among several drugmakers set to launch their biosimilar versions of Humira, which racked up $21.2 billion in sales last year. Pfizer has high hopes for Abrilada, which is under review from the FDA to gain a valuable “interchangeable” designation. Boehringer Ingelheim just launched its own Cyltezo, the first interchangeable Humira biosimilar available in the U.S. Pfizer's biosimilar portfolio also features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus versions of Johnson & Johnson's Remicade and Amgen’s Neupogen.