Viatris Archives - Medical Design Sourcing

Viatris, Kindeva win FDA approval for first generic version of Symbicort inhalation aerosol

Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort.

In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for the drug-device combination product for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

Get the full story at our sister site, Drug Delivery Business News.

FDA approves first generic of Symbicort for asthma and COPD

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…

Viatris sell biosimilar business to Biocon for $3 billion

Viatris (NASDAQ: VTRS) shares skidded 24% yesterday to $11.01 after announcing it would sell its biosimilars portfolio to Biocon Biologics for as much as $3.335 billion.

The former company unveiled the news when announcing its fourth-quarter earnings. Viatris will pay $2 billion upfront, $1 billion in convertible preferred equity, and $335 million in additional payments as part of the transaction.

Viatris was created in 2020 as the merger of Mylan and Pfizer’s Upjohn unit.

The company plans to sell a number of assets that could generate up to $6 billion in pretax proceeds by the end of 2023.

In related news, Viatris also announced plans to settle litigation related to the EpiPen auto-injector for $264 million. A judge still must sign off on the proposed settlement.

The litigation relates to lawsuits filed against the Viatris predecessor company Mylan, accusing the company of raising the prices of the EpiPen from $100 to $608.

VTRS sh…

FDA approves generic for dry-eye treatment Restasis

Viatris (NSDQ:VTRS) has received FDA approval for the first generic of Restasis (cyclosporine ophthalmic emulsion) eye drops.

FDA first approved the drug, which was developed by Allergan, in 2003.

Now marketed by AbbVie (NYSE:ABBV), Restasis sales are on the order of $1.2 billion annually.

AbbVie recently noted in its projections for 2022 that it expected to maintain U.S. exclusivity of the drug.

Although no longer covered by patent protection, “the complex nature of the product” delayed the launch of a generic, wrote Truist analyst Gregory D. Fraser in a briefing note.

Generic Restasis revenue could be “a material sales contributor for VTRS given the size of the market and potential for limited competition,” Fraser said.

To attempt to discourage generic competition tied to Restasis, Allergan transferred six patents related to the drug to the St. Regis tribe of the Mohawk people in 2017. Allergan made an upfront payment of $13.75 mi…

Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined assessments on environmental, social and corporate governance performance.

Gilead Sciences (NSDQ:GILD), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) were among the pharmaceutical companies to land a spot in the top-500, with a number of other drug development, pharmaceutical processing and manufacturing companies included.

The highest-ranking company was Gilead in sixth, landing an overall score of 89.9 points (90.6 environmental, 81.1 social and 98.2 corporate governance).

Merck was next-best in ninth at 89.3 points (94.6, 81.4, 92.…

Prime Therapeutics to prefer Viatris’ interchangeable insulin biosimilar

Pharmacy benefit manager Prime Therapeutics announced today that it will prefer Viatris’ (NSDQ:VTRS) Semglee insulin biosimilar injection on its national formularies as part of the pharmacy benefit.

In July, the FDA cleared the Semglee insulin glargine-yfgn injection, developed by Viatris in collaboration with Biocon Biologics, as a biosimilar for controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes.

Get the full story at our sister site, Drug Delivery Business News.

FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics

Viatris (NSDQ:VTRS) and Biocon Biologics announced FDA clearance for their Semglee insulin glargine-yfgn injection as a biosimilar.

Semglee holds indication for controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes. The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The product is sold in a pre-filled disposable pen.

Get the full story at our sister site, Drug Delivery Business News.

Pfizer, subsidiaries agree to pay $345M in EpiPen pricing lawsuit

Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices.

Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by Pfizer and its Mylan subsidiary, which markets the EpiPen.

Get the full story at our sister site, Drug Delivery Business News.

Pfizer, subsidiaries agree to pay $345M in EpiPen pricing lawsuit

Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices.

Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by Pfizer and its Mylan subsidiary, which markets the EpiPen.

Get the full story at our sister site, Drug Delivery Business News.

Kansas Distric Court rules in favor of Mylan in EpiPen class action

Viatris (NSDQ:VTRS) announced that the U.S. District Court for the District of Kansas ruled in favor of Mylan in an EpiPen class action.

Mylan, which Pfizer combined with its Upjohn business to form Viatris in November 2020, received a favorable ruling in substantial part that dismissed all of the plaintiffs’ claims under the federal RICO statute, including claims asserted against former Mylan CEO Heather Bresch.

Get the full story at our sister site, Drug Delivery Business News.

Mylan must face EpiPen racketeering lawsuit

A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device.

Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming that Mylan paid bribes and kickbacks to a group of pharmacy benefit managers (PBMs) —referred to collectively as CVS Caremark, Express Scripts, and OptumRx — to ensure that Mylan could raise the price of its EpiPen auto-injector with impunity while also keeping a monopoly share of the market. The cases were consolidated in August.

Mylan and the PBM defendants filed separate motions to dismiss for failure to state a claim. The PBMs also argued that Rochester Drug and Dakota Drug have not alleged plausible racketeering claims, that the claims are time-barred, and that the claims against the PBMs’ corporate parents should be…