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Insight & Intelligence : Apr 29, 2013
Biosimilars: 10 Drugs to Watch
Which innovator drugs are companies scrambling to copy?!--h2>
The world’s largest two markets for prescription medicines remain a study in contrasts: The European Medicines Agency authorizes 11 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.
Those guidances, released last year, left numerous questions unanswered: How similar should the near-copies be to their innovator drugs? How should drugmakers demonstrate the safety of their products? How should interchangeability of biosimilars to innovator products be determined? How should biosimilars be named and labeled? Biopharma companies are closely watching what FDA does since patents for 12 blockbuster biologic compounds generating a combined $67 billion in sales will expire by 2020, according to the Generics and Biosimilars Initiative. Biopharma companies don’t want to be left behind as the biosimilar segment grows—from $172 million in 2010 to an estimated $3.927 billion by 2017, according to Frost & Sullivan.
EMA defines biosimilars as “similar to a biological medicine that has already been authorized, the so-called reference medicinal product.” FDA has proposed using slightly stricter wording, declaring that, in order to be considered a biosimilar, the biological product must be “highly similar to the reference product notwithstanding minor differences in clinically inactive components.” By minor differences, the agency states that there should be no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
As reported in this space last year, “EMA’s development of solid guidelines almost a decade ago followed by specific rules for different drug classes helps explain why Europe is much further along than the U.S. in bringing biosimilars to market.” Little has changed since then.
You've already seen a list of the top 20 best-selling drugs approved and launched during 2012; now, following is a list of 10 drugs for which biosimilars are either being marketed somewhere in the world, are in clinical development, or in some cases, whose development was ended within the past year. 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 2012 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.
2012 sales: $2.040 billion (Amgen)
Patent status: Patent set to expire 2016 in EU; 2024 in U.S.
Recently discontinued effort: Merck & Co. and Hanwha Chemical: Hanwha disclosed December 18, 2012, that Merck terminated agreement to develop and manufacture the biosimilar MK-8953, now called HD203, as well as market it in all countries except South Korea and Turkey, an up to $720 million deal signed June 2011.1
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
2012 sales: $7.963 billion (includes $4.236 billion Amgen + $3.737 billion Pfizer). Amgen markets Enbrel in U.S. and Canada under an agreement with Pfizer set to expire October 31, 2013
Patent status: Patents set to expire in EU in 2015; in U.S., 2019, 2023, 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
2012 sales: $2.267 billion, including $1.941 billion for Epogen (Amgen), and $326 million combined for Procrit / Eprex / Erypo (Johnson & Johnson) Amgen also generated
Patent status: Patent set to expire 2015 in U.S.; expired 2004 in EU
Genotropin (Somatropin or somatotropin)
Nature and indication: Peptide human growth hormone for children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, small for gestational age, Turner syndrome, and idiopathic short stature; and for adults with either adult onset or childhood onset GHD. Pursuing FDA approval since 2009 for additional indication, Replacement of human growth hormone deficiency (Mark VII multidose disposable device); received two complete response letters. “We are working to address the FDA's requests for additional information,” Pfizer stated in its 2012 Financial Report.
2012 sales: $832 million (Pfizer)
Patent status: Patents expired 2008 and April 16, 2013 in U.S.
Nature and indication: Monoclonal antibody; 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.
2012 sales: $6.317 billion (CHF 5.889 billion) (Roche)2
Patent status: Patents set to expire July 2014 in Europe, and June 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
2012 sales: $9.265 billion (AbbVie)3
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
2012 sales: $4.092 billion
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
2012 sales: $1.260 billion (Amgen)
Patent status: Patent set to expire 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 six 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 six years and older and adults that have not responded well to other medicines.
2012 sales: $8.215 billion ($6.139 billion Johnson & Johnson + $2.076 billion Merck & Co.)
Patent status: Patents set to expire 2014 in Europe, and 2018 in U.S.
Rituxan / MabThera (rituximab)
Recently discontinued efforts:
Nature and indication: Chimeric mouse-human monoclonal antibody, for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis
2012 sales: $7.190 billion (CHF 6.707 billion) (Roche)5
Patent status: Patents set to expire later this year in EU, and 2018 in U.S.
Among other drugs for which biosimilar efforts have been announced in recent months:
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