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After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.
Celltrion s Humira Biosimilar approved and set for launch in Europe
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Celltrion Healthcare will bring its parent company’s adalimumab biosimilar called Yuflyma to Europe next month. The company is in charge of Celltrion’s businesses overseas, and it will be launching the said biosimilar drug and start its sale in European countries.
The launch of Yuflyma
As per The Korea Herald, Celltrion will introduce Yuflyma in six European regions at first. A company official reportedly said that they will attempt to release the product in Spain this coming June, but this date could still change.
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During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira
®, which had sales of about $20 billion in 2020. While none have launched thus far, at least eight adalimumab biosimilars are due to launch by the end of 2023 in the United States, where Abbvie secured over $16 billion of its Humira
® sales revenues in 2020.
On February 11, 2021, the European Commission (EC) granted marketing authorization for Celltrion’s Yuflyma
TM for use in treating thirteen chronic inflammatory diseases. This authorization is valid in all EU Member States and the European Economic Area countries Iceland, Liechtenstein, and Norway. According to Celltrion, Yuflyma