PHARMACY

Contract manufacturing to get a big boost from biosimilar approvals

BY Michael Johnsen

NEW YORK – The U.S. Food and Drug Administration's (FDA) recent approval of Zarxio (filgrastim-sndz) – the first biosimilar product approved in the United States – points toward growth in the contract manufacturing organization industry, Kalorama Information reported Friday. The mainstream CMO industry is geared to the production of small-molecular drugs and lacks the infrastructure to produce major biopharmaceutical products. 
 
The healthcare market research publisher's report, "Biopharmaceutical and Vaccine Production Markets," found that, though there are uncertainties, a large number of CMOs are positioning themselves to capitalize on the anticipated increase in the demand for biomanufacturing.
 
Sandoz' Zarxio, approved in March, is biosimilar to Amgen's Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy and patients with severe chronic neutropenia.
 
"The most volatile factor in CMO growth is likely to be the approval and adoption of biosimilar products," said Bruce Carlson, publisher of Kalorama Information. "If these biologic generics deliver on the promise of massive cost savings for extremely expensive biopharmaceuticals, growth of biosimilars will spur dramatic growth in contract manufacturing production capacity. "  
 
Further the report says that since many biosimilar developers cannot lay claim to their own biomanufacturing facilities – and that a significant number of follow-on versions are successful for each current successful product – we can expect that the CMO market will profit from biosimilars development, with active pharmaceutical ingredients biologics manufacturing in particular an area of demand.
 

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Aurobindo Pharma submits for tentative approval of new HIV medicine

BY Michael Johnsen

LONDON – ViiV Healthcare, Aurobindo Pharma and the Clinton Health Access Initiative announced Tuesday that Aurobindo Pharma has submitted an abbreviated new drug application for dolutegravir 50 mg to the Food and Drug Administration for the treatment of HIV. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of ViiV Healthcare's Tivicay (dolutegravir) for sale in the United States.
 
"This first ANDA for a generic dolutegravir confirms that our strong commitment to thinking and acting differently to pursue new ways to expand access to our medicines, for people living with HIV in countries where the need is most pressing, is working," stated Dominique Limet, CEO, ViiV Healthcare. 
 
Upon receiving tentative approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President's Emergency Plan for AIDS Relief program, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014.
 
This submission comes less than five years after ViiV Healthcare and CHAI signed an agreement to collaborate with the goal of bringing innovative formulations of medicines for the treatment and prevention of HIV/AIDS to people living with HIV in developing countries, on an affordable yet sustainable basis.
 
CHAI and ViiV Healthcare worked together to identify a generic partner after conducting feasibility research. Following this initial joint work, ViiV Healthcare submitted necessary documentation to the FDA providing a selective waiver letter for the five-year period of New Chemical Entity exclusivity that would have otherwise prevented FDA review and tentative approval of Aurobindo Pharma's ANDA at this time.
 
The filing by Aurobindo Pharma is the second result of the agreement between CHAI and ViiV Healthcare and comes less than six months after another generic manufacturer announced that it had received tentative approval from the FDA for pediatric formulations of another ViiV Healthcare antiretroviral (also under PEPFAR for sale in licensed countries outside of the United States), through innovative collaboration with ViiV Healthcare and CHAI.
 

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21st Century Cures legislation is gaining momentum

BY DSN STAFF

 
 
WASHINGTON – The 21st Century Cures legislation spearheaded by Reps. Fred Upton, R-Mich., and Diana DeGette, D-Colo., is gaining momentum in the House Energy and Commerce Committee.
 
“We in Congress are going to take a comprehensive look at what steps we can take to accelerate the pace of cures in America,” the congressional leaders stated in first announcing the initiative. “We are looking at the full arc of this process — from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase.”
 
Upton, chairman of the Energy and Commerce Committee, has said he wants legislation aimed at accelerating cures and treatments for diseases on the president’s desk by the end of this year.
 
“Over the past two weeks, the 21st Century Cures initiative has moved through the Energy and Commerce Health Subcommittee and full committee, enjoying momentum from a continued flood of support,” the Committee noted on its web page on Friday.  “For more than a year, committee members have brought patients, innovators, caregivers, regulators, researchers, and other thought leaders to the table for an open and collaborative conversation. Their common goal: building a 21st Century health care system that embraces personalized medicine and advances in technology, encourages greater innovation, supports more research, and streamlines the system so patients ultimately gain access to more cures and treatments more quickly.”
 
“GPhA commends House Energy and Commerce Committee chairman Fred Upton, ranking member Frank Pallone [D-N.J.], Rep. Diana DeGette, Health Subcommittee chair Joe Pitts [R-Pa.], and Health Subcommittee ranking member Gene Green [D-Texas] for their bipartisan leadership around fostering the development of new cures while recognizing the balance between pharmaceutical competition and innovation,” stated Ralph Neas, president and CEO for the Generic Pharmaceutical Association. "GPhA and its members look forward to continuing to work with the Committee and stakeholders on the 21st Century Cures initiative to ensure and protect that balance."
 
“The thoughtful, year-long process that brought countless stakeholders to the table ultimately results in important steps forward for patients,” added John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America. “Exempting future Food and Drug Administration user fees from sequestration is critical to ensuring the FDA is able to fulfill its public health mission by fostering timely patient access to safe and effective new medicines and advancing regulatory science. We are pleased to see this important provision included in the legislation.”
 

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