Concerns Raised Over the Comparability of Branded/Generic-Drugs

Stephanie Sutton Pharm Tech EuropeLast week, FDA deemed that a generic drug manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA was not therapeutically equivalent to its reference product. The drug in question, Budeprion XL 300 mg, was approved in the US in December 2006 as a generic form of GlaxoSmithKline’s antidepressent drug, Wellbutrin XL 300 mg. Read more »

Generic Drug and Biosimilar User Fees Gain Traction

Patricia Van Arnum PharmTech editor FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

Drugmakers Seek to Outwit Generic-Drug Competitors

Erik Greb PharmTech editorThe day of reckoning is here. As patent protection expires for top-selling drugs, some firms are scrambling to stay one step ahead of generic-drug competitors. As Amy Ritter wrote last week, Pfizer is drawing scrutiny by asking pharmacy benefit managers to block pharmacies from filling prescriptions with generic alternatives to Lipitor, in exchange for a discount on the product. Rep. John Sarbanes (D-MD) asked the Federal Trade Commission to take action against this arrangement, but another tactic is also causing concern. Read more »

EMA Stats Point To Improved Pipelines

Stephanie Sutton Pharm Tech EuropeThe end of the year is just around the corner so I thought I’d spend some time today looking at how marketing authorisation applications are progressing at the European Medicines Agency. The past few years have witnessed some dreary numbers in both Europe and the US when it comes to new products, but the figures for 2011 could be early indicators for a 2012 upturn. Read more »

QbD in Theory and Practice

Erik Greb PharmTech editorThe pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

FDA Follows EMA toward Follow-On Biologics

Erik Greb PharmTech editorDuring this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

Drugmakers, Uncle Sam Wants You to Help Reduce Spending

Erik Greb PharmTech editor

It’s crunch time on Capitol Hill. Before Congress will consider raising the debt ceiling by next week’s deadline, they have insisted on achieving a budget deal that will reduce the federal debt over the long term. Tensions have mounted as President Obama and leading lawmakers have taken turns grandstanding and negotiating. Both parties agree that spending cuts should be part of the budget deal, and some Democrats have expressed willingness to find opportunities for savings in Medicare and Medicaid. But these programs might now be spending less money if one bill on the Senate’s calendar had passed when it was originally introduced. Read more »

Protection for Generics Companies, But Not Patients

Erik Greb PharmTech editorIn a decision handed down late last week, the US Supreme Court gave manufacturers of generic drugs significant legal protection from liability. In Pliva v. Mensing, the Court ruled that patients cannot sue these companies under state law for failing to warn them about the risks associated with their drugs. Although generic-drug firms may welcome the decision, I think it has unpalatable implications. Read more »

Diligence Is Our Due

Erik Greb PharmTech editorIn 2010, the US House of Representatives’s Committee on Oversight and Government Reform held two hearings after scandalous cGMP violations at McNeil’s Puerto Rico facilities came to light. Former FDA Deputy Commissioner Joshua Sharfstein told the Committee that the agency would review McNeil’s plan for correcting deficiencies to ensure that the corrective actions were effective. “FDA intends to keep a close eye on these facilities until the company earns our confidence back,” said Sharfstein. Read more »

Will Senator Kohl Thwart Drugmakers’ Strategy for Survival?

Erik Greb PharmTech editorMakers of small-molecule drugs are in treacherous waters. The Scylla of generic-drug competition rears on the horizon, ready to bite into innovators’ profits. At the same time, companies’ research-and-development productivity seems to have been sucked down into Charybdis. How will drugmakers survive these perils? Read more »

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