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Insight & Intelligence : May 19, 2014
Biosimilars: 11 Drugs to Watch
If imitation is the sincerest form of flattery, these innovator drugs should be blushing.!--h2>
May 9 saw the latest estimate of the potential size of the market for biosimilar drugs—$167 billion by 2017, according to Companiesandmarkets.com. It’s an exponential leap from the estimate made earlier this year by Frost & Sullivan that biosimilar sales will reach $23 billion in 2019, up from what it estimated as $1.2 billion in 2013 sales.
The past few years has seen a flurry of worldwide activity by drug developers in creating, winning regulatory approvals for, then launching biosimilars. The operative word here is “worldwide”—Europe remains miles ahead of the U.S. The European Medicines Agency authorizes 18 biosimilar drugs for market in the nations comprising the EU. Meanwhile in the U.S., the FDA continues to ponder draft guidances for how the agency will evaluate biosimilars.
FDA insists it is moving ahead with careful review of new regulations. FDA’s Center for Drug Evaluation and Research (CDER) earlier this year published an agenda for new and revised draft guidances that included several new topics the agency said will be addressed: clinical pharmacology data to support a demonstration of biosimilarity to a reference product; considerations in demonstrating interchangeability to a reference product; labeling for biosimilar biological products; and reference product exclusivity for biological products. CDER also included a biosimilar topic published in previous agendas, additional questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009.
One reflection of increased activity: This year’s list reports on 11 biosimilars to watch, as Avastin (bevacizumab) and Erbitux (cetuximab) have been added to reflect an uptick in announcements or disclosures about biosimilar versions of those drugs since 2013, while Genotropin (somatropin or somatotropin) has been removed for not generating as much activity.
Following is a list of 11 drugs for which, over the past year, biosimilars have been launched to market somewhere in the world, were in clinical development, or whose development was ended. Drugs are listed by original brand name (generic name), followed by a list of drug developers with a brief summary of the status of their biosimilar, and its name where known; the nature of the drug and its indication; its 2013 sales (and the original drug’s maker or makers); and the drug’s patent status in the U.S. and EU.
Aranesp (darbepoetin alfa)
Nature and indication: Erythropoiesis-stimulating agent (ESA) for anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis; the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
2013 sales: $1.911 billion, down 6% from 2012 (Amgen)
Patent status: Patent set to expire 2016 in EU; 2024 in U.S.
Nature and indication: Vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of: Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment; Metastatic colorectal cancer, with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen; Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease; Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy; Metastatic renal cell carcinoma with interferon alfa
2013 sales: $7.106 billion (CHF 6.254 billion) (Roche), up 8.5% from 2012
Patent status: Patent set to expire 2018 in Europe; 2019 in U.S.
Nature and indication: Tumor necrosis factor (TNF) blocker for rheumatoid arthritis, polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged two years or older; psoriatic arthritis; ankylosing spondylitis; and plaque psoriasis
2013 sales: $8.760 billion (including $4.551 billion Amgen + $3.774 billion Pfizer + $0.435 billion Takeda)3
Patent status: Patents set to expire February 2015 in EU; U.S. patents set to expire 2028 and 2029
Epogen / Procrit / Eprex / Erypo (epoetin alfa)
Nature and indication: Erythropoiesis-stimulating agent for anemia due to chronic kidney disease in patients on dialysis and not on dialysis; due to Zidovudine in HIV-infected patients; and due to effects of concomitant myelosuppressive chemotherapy, where upon initiation, there is a minimum of two additional months of planned chemotherapy. Also, for reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery
2013 sales: $3.317 billion (including $1.953 billion for Epogen [Amgen], and $1.364 million combined for Procrit / Eprex [Johnson & Johnson], down 2.5% from 2012
Patent status: Patent set to expire 2015 in U.S.; expired 2004 in EU
Nature and indication: Epidermal growth factor receptor (EGFR) antagonist indicated for locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy; recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU; recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy; KRAS mutation-negative (wild-type), EGFR-expressing, metastatic colorectal cancer in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, or as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan
2013 sales: $2.283 billion ($1.222 billion [€882 million] Merck KGaA + $696 million Bristol-Myers Squibb [BMS] + $373.7 million Eli Lilly [ImClone subsidiary]), down 1.7% from 2012
Patent status: Patent set to expire in Europe June 29, 2014; data exclusivity ends 2016 in U.S. As a biologic there is no patent that specifically claims the composition of matter of cetuximab.
Nature and indication: Monoclonal antibody; erbB2 TK Inhibitor; human epidural receptor 2 (neu) receptor antagonist for aggressive HER positive metastatic and adjuvant breast cancer, for aggressive HER positive metastatic stomach or gastroesophageal junction cancer.
2013 sales: $6.908 billion (CHF 6.079 billion) (Roche), up 3.2% from 2012
Patent status: Patents set to expire July 28, 2014, in Europe, and 2019 in the U.S.
Nature and indication: Anti-TNF-α monoclonal antibody for moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe Crohn’s disease; moderate to severe ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, moderate to severe polyarticular juvenile idiopathic arthritis
2013 sales: $10.659 billion (AbbVie)
Patent status: Patent set to expire 2016 in U.S.; 2018 in EU
Nature and indication: Leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia
2013 sales: $4.392 billion (Amgen), up 7% from 2012
Patent status: Patents set to expire August 2015 in EU; October 2015 in U.S.
Nature and indication: Granulocyte colony-stimulating factor (G-CSF) for neutropenia caused by the drugs used to treat cancer
2013 sales: $1.398 billion, up 11% from 2012 (Amgen)5
Patent status: Patent expired December 2013 in U.S.; Patent expired 2006 in EU
Nature and indication: Tumor necrosis factor (TNF) blocker for moderately- to severely-active rheumatoid arthritis in adults, in combination with methotrexate; Crohn's Disease in children 6 years and older, and adults who have not responded well to other medicines; rheumatoid arthritis; ankylosing spondylitis; psoriatic arthritis; chronic, severe, extensive, and/or disabling plaque psoriasis in adults; moderately to severely active ulcerative colitis in children 6 years and older and adults that have not responded well to other medicines.
2013 sales: $8.944 billion ($6.673 billion Johnson & Johnson + $2.271 billion Merck & Co.), up 8.9% from 2012
Patent status: Patents set to expire February 2015 in Europe, and 2018 in U.S.
Rituxan / MabThera (rituximab)
Nature and indication: Chimeric mouse-human monoclonal antibody, for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis
2013 sales: $8.998 billion [$7.898 billion (CHF 6.951 billion) Roche + $1.1 billion Biogen Idec], up 3.2% from 20126
Patent status: Patents expired November 2013 in EU, and set to expire 2018 in U.S.
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