fda-approval-letter
PHARMACY

FDA approves Fulphila, the first U.S. Neulasta biosimilar

BY David Salazar

The Food and Drug Administration on Tuesday approved Fulphila (pegfilgrastim-jmdb), a Neulasta biosimilar from Mylan and Biocon. Fulphila is the first U.S. biosimilar of the drug from Amgen and is indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy in certain types of cancer.

“Today’s approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the United States,” Mylan president Rajiv Malik said. “It also is yet another confirmation of Mylan’s deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognized in the industry and bolster Mylan’s reputation as a partner of choice in the global effort to bring complex medicines to market.”

Fulphila is the second approved biosimilar from Mylan and Biocon’s joint portfolio. In December 2017, the two companies received approval for Ogivri, the first Herceptin biosimilar in the United States.

“This approval expands our oncology portfolio for the benefit of cancer patients and supports our mission to improve access to high quality, affordable biopharmaceuticals globally,” said Biocon CEO and joint managing director Arun Chandavarkar.

Though Fulphila is the first U.S. Neulasta biosimilar, last week, Health Canada approved Lapelga, a Neulasta biosimilar from Apotex’s Apobiologix division.

As more approvals roll in for biosimilars, FDA commissioner Scott Gottlieb has promised more action on the medications that are priced lower than their reference products.

“This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development,” Gottlieb said. “Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”

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PHARMACY

Lupin intros generic Methergine tablets

BY David Salazar

Lupin has launched its generic Methergine tablets (methylergonovine), having previously received approval from the Food and Drug Administration. The drug is indicated to treat and prevent postpartum hemorrhage.

Lupin’s generic Methergine tablets will be available in 0.2-mg dosage strength. The product’s market size was $71.5 million for the 12 months ended April 2018, according to IQVIA data.

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FDS names new CEO

BY David Salazar

Pharmacy technology company FDS has new leadership. The Fort Worth, Texas-based company on Monday named Adam McMullin CEO, effective immediately. McMullin — who has leadership experience in healthcare IT — succeeds FDS’ seven-year CEO Jake Canova, who the company will continue on in an advisory capacity.

“We are very pleased to partner with Adam to lead FDS,” said Michael Booth, a partner with FDS majority shareholder Calvert Street Capital Partners. “His broad experience in healthcare IT will be invaluable as the company continues to innovate and grow in pharmacy technology and beyond.”

McMullin joins the company from Voalte, where he was chairman and CEO . he also has led Hill-Rom’s clinical workflow solutions business, doubling the unit’s revenues and improving earnings within five years. He spent more than a decade at IBM in various management roles.

Adam McMullin FDS“FDS has built a strong reputation in the market based on its team’s deep commitment to customer success and its unique solutions that help ensure patients are getting the medications they need while improving pharmacy efficiency and profitability,” said McMullin. “Pharmacies represent a key part of our health system, playing a critical role in improving wellness within communities. While we will continue delivering high-value solutions and outstanding services to pharmacies, we also see many opportunities for innovations that will further help pharmacies and improve population health. I look forward to building on FDS’s leadership position and continuing to grow the business.

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