2011: The Year of the Biosimilar

Patricia Van Arnum PharmTech editor Only a few weeks into the new year, biosimilars or follow-on biologics already are occupying a prominent space in public policy and business developments. Following hearings in November 2010, FDA will continue to pave a regulatory pathway for biosimilars in the United States. On the other side of the Atlantic, the six-month consultation period on the draft guidelines issued by the European Medicines Agency on biosimilar monoclonal antibodies will end in May 2011. As these key regulatory matters are considered, both large and small bio/pharmaceutical companies are positioning themselves in the biosimilars market. Read more »

EU Considers Guidelines for Biosimilar mAbs

Patricia Van Arnum PharmTech editor The European Medicines Agency (EMA) is expected to release shortly for public consultation guidelines for biosimilars for monoclonal antibodies (mAbs). As the regulatory environment for biosimilar mAbs begins to be debated, how strong is their market potential? Read more »

Of Genes, Coal, and the US Government

Erik Greb PharmTech editorBiopharmaceutical manufacturers have successfully patented isolated DNA molecules for some time. The Biotechnology Industry Organization recently described these patents as critical tools that enable the research and development of new biotech therapies. A new development in a federal court case, however, could redefine what legitimately can and cannot be patented. The court’s decision could have ramifications for all biopharmaceutical manufacturers. Read more »

Is Healthcare Reform Socialism?

Erik Greb PharmTech editorThe dust has partly settled since President Obama signed the “Health Care and Education Affordability Reconciliation Act of 2010.” By now, analysts have had a chance to examine the act’s details and get a sense of what practical effects the legislation will have. So what will healthcare reform mean for pharmaceutical manufacturers? Read more »

Healthcare Reform Passes Final Legislative Hurdle, So What’s Next?

Patricia Van Arnum PharmTech editor The legislative battle for healthcare reform ended on Thursday night Mar. 25 following the passage by both houses of Congress of a slightly amended version of “The Healthcare and Education Reconciliation Act” (HR 4872), the so-called “fixer bill” to the “Patient Protection and Affordable Care Act” (HR 3590), the healthcare reform legislation that was passed by the US House of Representatives on Sunday Mar. 21 and signed into law (Public Law No,111-148) by President Barack Obama on Tuesday Mar. 23. The reconciliation legislation (HR 4872) now goes to the President for his signature, which would clear the last hurdle for healthcare reform after a grueling week of intense debate and parliamentary efforts to both advance and stop final passage. The debate on the myriad of measures in the healthcare reform package will no doubt continue, but as the dust settles, at least momentarily, what are some of the implications for the pharmaceutical and biotechnology industries? Read more »

Genzyme’s Friday the 13th

Erik Greb PharmTech editorFriday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

BIO–1, GPhA–0

Erik Greb PharmTech editorThe Biotechnology Industry Organization (BIO) has won the latest battle over follow-on biologics. Last week, the House Energy and Commerce Committee approved Rep. Anna Eshoo’s (D-CA) amendment to the America’s Affordable Health Choices Act (H.R. 3200). The Eshoo amendment, a regulatory pathway for the approval of biosimilars, would grant about 12 years of market exclusivity to each new biological medicine. Read more »

Same Fight, Different Day

Erik Greb PharmTech editorLast week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) released dueling statements about the proposal to establish an approval pathway for follow-on biologics that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is considering. Are the two antagonists advancing the debate? Read more »

Chutes, Ladders, and Healthcare Reform

Erik Greb PharmTech editorCongress has taken up the Obama administration’s goal of making healthcare more affordable by introducing various strategies for reducing the cost of prescription drugs. But the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization (BIO) have resisted several of Congress’s initiatives, and cost control has been elusive so far. Read more »

The Seven-Year Itch in Biologics Exclusivity

Patricia Van Arnum PharmTech editor In the debate over establishing a regulatory pathway for biologics, the White House recommended this week to limit data exclusivity for biologics to seven years, according to a Reuters report. Reuters reported that the Office of Management and Budget Director Peter Orszag and Nancy-Ann DeParle, director of the White House Health Reform Office, sent a letter to Representative Henry Waxman (D-CA), chair of the House Energy and Commerce Committee, whose committee is considering biosimilar legislation, stating that seven years “strikes the appropriate balance between innovation and competition.” As would be expected, supporters of limiting exclusivity such as the Generic Pharmaceutical Association (GPhA) applauded the proposal while the Biotechnology Industry Organization (BIO) raised concerns. Read more »

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