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GPhA meeting debates biosimilars laws

BY Alaric DeArment

NAPLES, Fla. —The topic of biosimilars occupied much of the Generic Pharmaceutical Association’s annual meeting in Naples, Fla., last month, including a video message from California Rep. Henry Waxman and a panel discussion between GPhA president and CEO Kathleen Jaeger and Biotechnology Industry Organization president and CEO Jim Greenwood.

In his address, Waxman argued in favor of applying to biosimilars the model of data exclusivity established in the Hatch-Waxman Act of 1984, the bill allowing generic drugs that he co-sponsored with Sen. Orrin Hatch.

“I may be biased, but the Waxman-Hatch model has worked well for 25 years,” Waxman said. “It achieves a strong balance between fostering innovation and making affordable medicines available to consumers.”

After Waxman’s remarks, CEOs from generic drug makers participated in a “CEOs Unplugged” session and reiterated their desire for Congress to pass legislation allowing an approval pathway for biosimilars.

The session was followed by the panel discussion with Greenwood and Jaeger. Both organization leaders agreed that the Food and Drug Administration should allow biosimilars, though they continued to disagree on the exclusivity periods, with Greenwood reiterating BIO’s preference for 14 years, compared with the five years that Hatch-Waxman provides.

“Yes, the devil is in the details,” Jaeger said. “We know the issue of exclusivity is likely the ‘gordian knot’ that must be cut loose for us to reach consensus and get legislation passed.”

The GPhA also announced its executive committee for the 2009-2010 term.

Teva North America president and CEO William Marth will be chairman, having most recently served as vice chairman on the GPhA’s board of directors, while Watson Pharmaceuticals president and CEO Paul Bisaro will take over as vice chairman. Rosendo Ferran, senior consultant for New Chemic, was re-elected as secretary-treasurer; Nycomed U.S. CEO Paul McGarty and Mylan COO and EVP Heather Bresch will serve as at-large members of the committee.

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Walgreens set to expand distribution capacity

BY Jim Frederick

WOBORN, Mass. Walgreens is expanding the distribution capacity at its Mt. Vernon, Ill.-based distribution center by adding more portable robotic picking devices and upgrading many of its traditional conveyor-based systems into automated zones for sortation and movement of items to be shipped.

Walgreens uses the Kiva Mobile Fulfillment System from Kiva Systems in Mt. Vernon to store inventory and pick replenishment orders for its 6,700 stores and specialty pharmacies. Expanding the system in that distribution center puts nearly 1,000 mobile robots under a single roof, according to Kiva.

The upgrade marks the third expansion of the robotic picking system at the center since its initial deployment in 2007, Kiva noted. It also heralds a doubling of the throughput capacity at the center, the company reports.

“Productivity metrics from previous rollouts far exceeded Walgreens’ specifications for pick rate, accuracy, cycle time, tote utilization and installation time,” said Kiva CEO Mick Mountz. “By doubling capacity we expect Walgreens to quickly achieve an extraordinary new level of strategic competitive advantage and productivity.”

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Congress takes up follow-on biologics bill

BY Drug Store News Team

The long-awaited breakthrough for follow-on biologics may be close at hand.

Prompted by a far more supportive President and the growing crisis in healthcare funding, Congress has again taken up the call for a bill that would create a regulatory pathway for FDA approval of generic versions of biologically-engineered drugs. And with the strong affirmation of President Obama, who has campaigned for such an approval pathway, the newest iteration of the bill stands a far better chance of passage than previous attempts in the House and Senate.

The Promoting Innovation and Access to Life-Saving Medicine Act could mark the most significant change to the delicate balance of power between the branded and generic drug industries since passage of the landmark Hatch/Waxman compromise bill in 1984, which ushered in the modern era of me-too medicines. Tellingly, one of the new bill’s sponsors is an architect of that 1984 legislation, Democratic Rep. Henry Waxman of California.

The push for follow-on biologics augers well for both health plan payers and patients coping with the sometimes staggering costs of critically important but expensive pioneer biologics, and for the generic drug industry itself as it faces a critical shortage of new marketing opportunities as the number of blockbuster drugs facing patent expirations dries up. A new pipeline of me-too biologics could help fill the gap.

“With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed,” stated Kathleen Jaeger, president and CEO, Generic Pharmaceutical Association.

Cost-saving considerations aside, there’s no disputing the business potential follow-on biologics represent. Bio-engineered pharmaceuticals and specialized, highly targeted medications aimed at serious chronic or life-threatening diseases represent the only major bright spot right now in the global pharmaceutical market, with growth rates that far outpace the sluggish market for mainline meds. Indeed, most of the drugs that have reached blockbuster status in recent years have been biologically engineered specialty meds.

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