WV MetroNews – Following FDA approval, Mylan set to launch biosimilar drug

KeepHealthCare.ORG – WV MetroNews – Following FDA approval, Mylan set to launch biosimilar drug

CHARLESTON, W.Va. — Mylan’s first FDA-approved biosimilar drug should be available in a matter of weeks, a company official said.

Mylan, which has a 3,000 employee operation in Morgantown, along with Biocon, received the approval for Fulphila, a biosimilar to the drug Neulasta, which targets infections suffered by some breast cancer patients as they are undergoing chemotherapy.

Marcie McClintic Coates

Mylan Head of Global Policy Marcie McClintic Coates told MetroNews the approval of the drug was a milestone for the company.

“Mylan has invested more than $1 billion in our biosimilar platform. We have more coming,” McClintic Coates said.

Biologic drugs, like Neulasta, are expensive and Mylan believes its product, Fulphila, will provide a much needed option.

“Being able to come out with alternatives to those in the same way that we have been able to help with many other drugs, traditional tablets and capsules and so forth. To bring generics is something really important to expand the number of people that have access to these medicines,” McClintic Coates said.

Mylan and Biocon haven’t yet set a price for Fulphila.

McClintic Coates, a White Sulphur Springs native, did interviews with several media outlets in the Mountain State last week, not only about the new drug, but also about the company’s efforts to better tell its story to West Virginians.

“We’ve been so busy building the company, we haven’t taken enough time to tell our story to other West Virginians to get excited about what does exist here and what role we’re doing for society out of here,” she said.

Mylan was created in 1961 as a drug distributor by Milan Puskar and Don Panoz. The first operation was in White Sulphur Springs. The company now employs 35,000 people across the world.

Mylan, which has had a long history of donating to efforts at West Virginia University, recently announced a $5 million gift to WVU that will focus on STEM education through the WVU Extension Program and 4-H.

“West Virginia’s in our roots and our blood. We want to reach kids in all 55 counties over the next 10 years. Not just to get them excited about STEM but also lend our science and our own learning to let kids here in West Virginia get exposed to what they may one day may be able to do and become,” McClintic Coates said.

Mylan laid off approximately 400 workers at its Morgantown operation in April that followed an approximate 300 worker layoff last November. McClintic said the “rightsizing” was necessary. The company still has 3,000 workers in Morgantown and is one of the large private employers in the state, McClintic Coates said.

“They (the layoffs) were about rightsizing to make sure that our size did not lend itself to a complexity that made it more difficult to keep up with the quality standards,” she said.

When asked if Mylan was now at the right size in Morgantown, McClintic Coates indicated the company is.

“We do. Now we have to execute and move forward with what we have and we’re really excited for the future for us as a company,” McClintic Coates said.

In October 2016, following criticism over pricing practices of its auto injection allergy drug, EpiPen, Mylan agreed to a $465 million settlement with the U.S. Department of Justice and federal regulators.

Source: http://wvmetronews.com/2018/06/10/following-fda-approval-mylan-set-to-launch-biosimilar-drug/

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