Alvotech ALVO announced that it received a complete response letter (CRL) from the FDA for the biologics license application (BLA) for AVT02. The biosimilar is being developed in collaboration with Teva Pharmaceutical TEVA.
Shares of ALVO and TEVA are trading down in pre-market hours.
The CRL from the FDA noted that certain deficiencies were found during a reinspection of Alvotech's Reykjavik facility. These deficiencies must be satisfactorily resolved before the application can be further approved.
AVT02 is a high-concentration biosimilar candidate forHumira (adalimumab), a drug used to treat autoimmune disorders such as rheumatoid arthritis and psoriasis.
Alvotech provided the FDA with comprehensive responses to the inspection observations on Apr 3, 2023, and is awaiting communication from the agency assessing those responses.
The satisfactory outcome of the facility reinspection is key to the approval of the second BLA for AVT02.The second BLA contains data to support approval as a biosimilar and additional information bracing potential interchangeability designation. The Biosimilar User Fee Amendment goal date for the application review is June 28, 2023.
Teva Pharmaceutical is one of Alvotech's commercial partners.
TEVA’s shares have plunged 9.1% in the past year compared with the industry's 16% decline.
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Alvotech's shares have gained 38% in the past year against the industry's 12.6% decline.
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The company’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease and cancer.
Alvotech Price and Consensus
Alvotech price-consensus-chart | Alvotech Quote
Zacks Rank & Stocks to Consider
Currently, Alvotech has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are Kala Pharmaceuticals KALA and Allogene Therapeutics ALLO, both carrying a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Kala have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. The company's shares have plunged 58.2% in the past year.
KALA's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company’s shares have plunged 38.8% in the past year.
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