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Mylan enters Humira biosimilar commercialization partnership

BY David Salazar

Mylan is working with Fujifilm Kyowa Kirin Biologics to commercialize a Humira biosimilar through a recently announced partnership. The Pittsburgh-based company said it would use its regulatory platform to submit Fujifilm Kyowa Kirin Biologics’ Humira biosimilar for approval and commercialization in Europe.

Humira, indicated to treat multiple chronic inflammatory conditions, had European sales of roughly $4.1 billion for the 12 months ended Dec. 31, 2017, according to IQVIA data.

“Expanding access to biologics through the introduction of biosimilars around the world is a key area of focus for Mylan,” CEO Heather Bresch said. “Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab biosimilar in Europe is an exciting advancement for Mylan and for patients who are living with chronic autoimmune conditions and need access to a high-quality, more affordable treatment option.”

Mylan said it expects to receive a decision from the European Medicines Agency in the second half of 2018 for the Humira biosimilar. The agreement will see Mylan paying an upfront fee to Fujifilm Kiowa Kirin Biologics, with eligibility for a subsequent commercialization milestone payment and sales royalties.

“Expanding access to biologics through the introduction of biosimilars around the world is a key area of focus for Mylan,” Rajiv Malik, Mylan president, said. “Our partnership with Fujifilm Kyowa Kirin Biologics for an adalimumab biosimilar in Europe is an exciting advancement for Mylan and for patients who are living with chronic autoimmune conditions and need access to a high-quality, more affordable treatment option.”

 

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Azar: Drug pricing efforts coming soon

BY David Salazar

Joining President Donald Trump at his unveiling of the Administration’s efforts to fight the opioid epidemic, Health and Human Services secretary Alex Azar said Monday that his agency would be putting forth plans to tackle drug prices in the coming weeks.

“We’re going to be rolling out, … in about a month, a whole slate of other proposals around how we decrease the price of drugs and how we bring discounts that the middlemen right now are getting; how those will go to our patients, to individuals.” Azar said.

In his comments, Azar, the former head of Eli Lilly, highlighted the efforts that the Food and Drug Administration has been undertaking to bring more generics to market. “Last year, the FDA approved more generic drugs than it ever has in its history. And that brings prices down for patients, for the system, for everybody,” he said.

So far this year, the FDA has approved 10 products that mark first-time generic entries, including generics for such drugs as Viread, Xyzal and Sensipar.

“You’ll be seeing drug prices falling very substantially in the not-too-distant future, and it’s going to be beautiful,” Trump said before praising FDA commissioner Scott Gottlieb, who has been spearheading the Generic Drug Action plan, among other efforts.

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Target announces extended holiday hours

BY Gisselle Gaitan

Target is catering to last-minute shoppers by extending store hours and offering convenient ways to obtain purchases before the holiday. The Minneapolis-based company has announced that up until December 23, all stores will open at 7:00 a.m., and close at midnight. On Christmas Eve, all Target locations throughout the nation will open at 7:00 a.m., and close at either 10:00 p.m., or 11:00 p.m.

The store also is offering free holiday shipping on orders placed online by 11:59 p.m., on December 20. The free holiday shipping option will be available to customers at checkout, with packages to be delivered by December 23.

Shoppers can have purchases delivered by December 23, when using the company’s Express one-day shipping option on online purchases made by 12:00 p.m. on December 22. Same-day order pickup also will be available nationwide until 6:00 p.m. local time on Christmas Eve.

“With just a week to go before Christmas, guests can feel confident they can get all their shopping done at Target – and on their terms,” Mark Tritton, executive vice president and chief merchandising officer at Target said. “Whether they take advantage of free shipping from Target.com, place an order for pickup, or stop by one of our more than 1,800 stores through Christmas Eve, Target is making it easier than ever for guests to save time and money on gifts, décor and everything else they need to pull off their holiday celebrations.”

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