Biosimilars—A New Frontier: Is the US Market Ready?

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This post has been updated based on FDA approval of Celltrion’s Inflectra™, a biosimilar Remicade® (infliximab) for treating arthritis and other inflammatory diseases, on April 5, 2016. Inflextra is the second biosimilar approved by the FDA and the first to be granted multiple indications. This is an important milestone for biosimilars in the United States.

Since the first FDA approval of a biosimilar in March 2015, biosimilars have quickly become one of the hottest topics in the US pharmaceutical industry. Why is this such a big deal, and is the US market ready?

Biosimilars are alternatives to innovative biologic therapies (known as “originator” products) such as Humira® (adalimumab) and Enbrel® (etanercept) for treating rheumatoid arthritis (RA) and psoriasis, or Herceptin® (trastuzumab) and Avastin® (bevacizumab) for treating cancer.

Biosimilars promise to increase access to these life-changing biologic therapies by reducing costs, analogous to the cost savings of generic drugs over brand-named drugs. In fact, biosimilars could save American consumers about $250 billion over the next 10 years.1

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Making Sense of FDA’s Expedited Drug Approval Pathways and Designations – for the Non-Regulatory Professional

blog header linkedin - FDA Approval v6 blog sizeOne of the fundamental responsibilities of the US Food and Drug Administration (FDA) is to approve effective medicines for people who need them, while upholding high standards for safety. That mission also demands that the FDA work efficiently and not delay approval of life-saving medical advances. Today, the FDA is reviewing applications for approval of new medicines faster than ever, and that’s a welcome change from the status quo 25 years ago. In the era from 1962 (immediately following the thalidomide recall) to the early 1990s, FDA review times for a New Drug Application (NDA) or Biologic License Agreement (BLA) were often measured in years rather than months. In 1993, the standard review time (from NDA or BLA submission to decision) for a new molecular or biologic entity (parlance for a drug not previously approved for any other use) was about 28 months,1 and in some cases, approvals were delayed for many years.

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President Obama’s Cancer Moonshot 2020 Initiative: How Big Is the Challenge?

Apollo rocket blasting offWhen President Obama’s White House Task Force meets for the first time this week, it faces a lofty charge: “Let’s make America the country that cures cancer once and for all.” His proposed Cancer Moonshot 2020 initiative will provide much needed funding for research, will encourage collaboration between industry and academia, and will undoubtedly lead to important advances in our understanding of cancer and how to treat it.

Although this initiative is noble and well intentioned, calling for a “cure for cancer” oversimplifies the challenge and is based on an outdated understanding of the disease.

The public needs to understand that cancer is not one disease; it’s hundreds of different diseases, and it’s more complex than anyone imagined back in 1971 when President Nixon first declared war on cancer. Those involved in cancer research know that conquering cancer, in all its varied forms, is truly a global endeavor that will require a sustained commitment for decades to come. While a challenge to be the “country that cures cancer” stirs our patriotic spirit and conviction that American biomedical know-how can render cancer irrelevant in our lifetime, the reality is that meaningful progress will require international collaboration.

Are we, as a nation, prepared to take on that challenge and lead such a charge? The President has taken the first step, appointing Vice President Joe Biden to lead the White House Task Force. But now the difficult work begins. Can we balance competing priorities and sustain both our political will and financial commitment for the many years that such an effort will undoubtedly take? Continue reading

Can You Predict Whether You Will Face an FDA Advisory Committee?

blog header linkedin - Prediction Ad Com v5 resizeThe US Food and Drug Administration (FDA) review of drugs, although guided by broad standards, remains individualized. Each drug or drug class faces unique challenges during the FDA review phase – thus no two reviews are exactly the same. Each review division within the FDA has its own approach, and evaluations often differ among the centers. To help understand the review process, the team at ProEd Regulatory sought to learn from the past to inform our future. We reviewed applications submitted to the Center for Drug Evaluation and Research (CDER) data over the last 70 years to see what patterns might emerge. Although the largest proportion of products (drugs and biologics) fails between discovery and Phase 3, an evaluation of applications submitted to the FDA over the last 70 years shows that the vast majority of products that reach the submission stage are ultimately approved (Figure 1).1
predict_fig_1It wasn’t until the Kefauver-Harris Drug Amendments of 1962 that the FDA required sponsors to demonstrate both efficacy and safety of their drugs prior to market access. In the wake of this significant legislation’s impact on drug development, we still see a consistent flow of approved applications and a corresponding subset of new molecular entities (NMEs) (Figure 2).1

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