Amgen, Watson partner on (bio)similar interests

Amgen has announced a new collaboration today with Parsippany, N.J.-based Watson Pharmaceuticals focused on exploring the potential of biosimilars.

Kelsey Kaustinen
THOUSAND OAKS, Calif.—Amgen has announced a newcollaboration today with Parsippany, N.J.-based Watson Pharmaceuticals focusedon exploring the potential of biosimilars. The two companies will collaborateon the worldwide development and commercialization of several oncology antibodybiosimilar medicines.
 
"This collaboration places Amgen and Watson in anunparalleled position in the global biosimilars market by capitalizing onbest-in-class capabilities in both innovative biologics and specialtypharmaceuticals and generics," Paul Bisaro, president and chief executiveofficer at Watson, said in a press release. "Forging this collaborationdelivers on the Watson promise to be a leader in the field of biosimilars, anddoes so in a way that helps manage the substantial financial investment,operational capabilities and broad commercial skills required to bring safe,high-quality and cost-effective biosimilar therapies to patients. We believethat biosimilars are the next frontier in the evolution of the healthcaremarket, and we are prepared to bring all of our resources to bear in thiscollaboration to ensure this partnership can most effectively compete in thebiosimilar space, and thereby generate significant long-term value for ourrespective shareholders."
 
 
Per the terms of the agreement, Amgen will be primarilyresponsible for the development, manufacture and initial commercialization ofthe oncology antibody products, and the agreement will not pursue biosimilarsof Amgen's proprietary products. For its part, Watson will contribute up to$400 million in co-development costs over the course of development. Itscontributions will include the provision of development support, and thecompany will also share product development risks. Additionally, Watson willcontribute its expertise to the commercialization and marketing of the productsin specialty and generic markets, including helping to manage the products'lifecycles effectively. The products will be sold under a joint Amgen/Watsonlabel, and Watson will initially receive royalties as well as sales milestonesfrom product revenues.
 
"The pairing of Amgen's 30 years of experience inbiologics together with Watson's substantial generics and specialty pharmaceuticalexperience and complementary commercial and distribution capabilities providesgreat potential for worldwide patient access to high quality oncologybiosimilar medicines," Robert A. Bradway, president and chief operatingofficer at Amgen, said in a press release. "Biosimilars provide anexciting long-term growth opportunity for Amgen. We have a dedicated team toleverage existing capabilities and capacity and drive the success of thecollaboration."
 
Biosimilars have been garnering more interest in recentyears. In an effort to improve access for biosimilars, Congress passed theBiologics Price Competition and Innovation (BPCI) Act of 2009, which authorizedthe U.S. Food and Drug Administration (FDA) to oversee an "abbreviated pathway"for the approval of biologics that are "biosimilar" to products that havealready secured approval. Since the abbreviated pathway will use knowledge fromthe reference products, it stands to eliminate unnecessary testing ofbiosimilars in animals and humans.
 
 
The BPCI Act requires the FDA to consult with public andbiosimilars industry stakeholders as it develops a biosimilars user-feeprogram, and Amgen was one of the companies that wrote in to the FDA to putforth its opinion. Amgen's recommendations consisted of the following: "usewell-designed clinical trials to establish biosimilarity," "ensure productmanufacturer and lot number are known for each biological" and "set scientificand practical criteria for interchangeability." In a transcript of the oraltestimony of Joseph Miletich, M.D., Ph.D., Senior Vice President of Researchand Development at Amgen, noted that the company believes that biosimilars"have a meaningful role to play in the U.S. healthcare system."

Kelsey Kaustinen

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