generic Archives - Medical Design Sourcing

A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…

First approved in 2006 as an asthma treatment, AstraZeneca’s (LON:AZN) Symbicort (budesonide/formoterol) has also won an indication related to chronic obstructive pulmonary disease (COPD).

Now, FDA has approved the first generic of Symbicort for both indications.

Viatris (Nasdaq:VTRS) partnered with Kindeva Drug Delivery (St. Paul, Minnesota) to manufacture the generic version.

Last week, the companies announced that FDA had tentatively approved the Symbicort generic as a result of patent litigation related to the drug in the U.S. District Court for the Northern District of West Virginia related to AstraZeneca’s Symbicort patents, U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137.

Symbicort and its generic are drug-device combination products, consisting of a metered-dose inhaler with the corticosteroid budesonide and the bronchodilator beta2-agonist formoterol.

“Today’s approval of the first generic for one of the most commonly pr…

generic

Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance

FDA approves first generic of Symbicort for asthma and COPD