Dawn of US Biosimilar Era Arrives

Mike Hennessy
Published: Monday, Jan 26, 2015
Mike Hennessy

OncLive Chairman,
Mike Hennessy

2015 has certainly got off to an exciting start in oncology! In a unanimous vote, the FDA’s ODAC panel recommended approval of EP2006, Novartis’s biosimilar version of filgrastim (Neupogen), Amgen’s synthetic G-CSF.

The committee backed EP2006 for all five of filgrastim’s indications, which include approvals for chemotherapy-induced febrile neutropenia in patients with nonmyeloid malignancies, for patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, and for cancer patients receiving bone marrow transplants.

The Biosimilars Act of 2010 established an expedited approval pathway for biosimilars. If the FDA follows ODAC’s recommendation and authorizes marketing of EP2006 under this pathway, EP2006 would become the first biosimilar approved in the United States.

And so, as we begin 2015, American healthcare is on the cusp of the biosimilar era, which has the potential to expand patient access and reduce healthcare costs.

Beyond coverage of this critical development, our inaugural issue of 2015 also includes highlights from the two major conferences that closed out 2014, the American Society of Hematology Annual Meeting and the San Antonio Breast Cancer Symposium.

Key areas from ASH highlighted in this issue include anti-CD38 antibodies in multiple myeloma (click here, to view more), frontline idelalisib monotherapy in older patients with chronic lymphocytic leukemia (click here, to view more), pembrolizumab in classical Hodgkin lymphoma (click here, to view more), CAR T-cell therapy in pediatric acute lymphoblastic leukemia (click here, to view more), elotuzumab in multiple myeloma (click here, to view more), brentuximab vedotin in hodgkin lymphoma (click here, to view more), nivolumab in classical Hodgkin lymphoma (click here, to view more), and ibrutinib combined with rituximab in mantle cell lymphoma (click here, to view more).

Important topics discussed at SABCS featured in this issue include ovarian suppression as a treatment option for younger, premenopausal breast cancer patients (click here, to view more); nab-paclitaxel versus conventional paclitaxel in high-risk early breast cancer (click here, to view more); upfront fulvestrant versus anastrozole in HR-positive metastatic breast cancer (click here, to view more); and immunotherapy with pembrolizumab in heavily pretreated patients with recurrent, metastatic triple-negative breast cancer (click here, to view more).

We look forward to continuing to cover groundbreaking developments in oncology for you throughout 2015. For additional coverage, visit our online platform at OncLive.com.

As always, thank you for reading.


View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective OnlineNov 30, 20183.0
Community Practice Connections™: Evaluating the Emerging Role of Biosimilar Agents for the Treatment of Hematologic MalignanciesMar 08, 20193.0
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