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Apr 29, 2013

Biosimilars: 10 Drugs to Watch

Which innovator drugs are companies scrambling to copy?

Biosimilars: 10 Drugs to Watch

The 10 innovator drugs below have biosimilars that are either being marketed, are in clinical development, or whose development was ended within the past year. [© Sebastian Kaulitzki - Fotolia.com]

  • 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)

    Drug developers:

    • Dr. Reddy’s Laboratories: Cresp® launched 2010 in India as that country’s only darbopoetin alfa of any kind, and as world’s first generic darbopoetin alfa.
    • Merck: MK-2578 development halted in 2010
    • Stada: Silapo® marketed in EU, where it was authorized December 2007 for anemia that is causing symptoms in patients with chronic renal failure; anemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions; and to increase the amount of blood patients with moderate anemia can self-donate before surgery.

    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.

  • Enbrel (etanercept)

    Drug developers:

    • Avesthagen: Avent™ in preclinical studies as of 2012
    • BioXpress Therapeutics: Biosimilar in active development
    • Cipla: Launches biosimilar in India on April 17, at a price of Rs. 6,150 ($113.43), 30% less than the innovator product.
    • Hanwha Chemical: HD203 “scheduled for launch,” company states on its website without including a date, following submission for marketing approval to South Korea’s Korea Ministry of Food and Drug Safety following completion of Phase I and Phase III trials. Hanwha has said it will seek a partner to commercialize HD203 and a biosimilar for Herceptin (trastuzumab).
    • LG Life Sciences: LBEC0101 completed Phase I trial in South Korea
    • Mycenax Biotech: TuNEX in Phase III clinical trials in Japan and South Korea
    • Protalix Biotherapeutics: PRX-106 in preclinical studies
    • Shanghai CP Goujian Pharmaceutical: Etanar®, marketed in Colombia; Yisaipu, marketed in China

    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)

    Drug developers:

    • Hexal: Epoetin alfa Hexal marketed in EU, where it was authorized August 2007 for anemia, cancer and chronic kidney failure
    • Hospira: Retacrit® marketed in EU, where it was authorized in December 2007 for anemia associated with chronic renal failure or other kidney problems, adults receiving chemotherapy for some cancers. Also indicated to increase the amount of blood patients with moderate anemia can self-donate before surgery, and to reduce the need for blood transfusions in patients with moderate anemia about to undergo major bone surgery. In U.S., Phase III trial launched last year. 
    • Medice: Abseamed® marketed in EU, where it was authorized August 2007 for anemia, cancer, and chronic kidney failure
    • Sandoz: Binocrit® marketed in EU, where it was authorized August 2007 for anemia and chronic kidney. In U.S., the company said October 25, 2012, that it has started patient enrolment in a Phase III clinical trial, comparing safety and efficacy of biosimilar with reference product Epogen® /Procrit® in anemia associated with chronic kidney disease.

    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)

    Drug developers:

    • BioPartners: Valtropin® marketed in EU, where it was authorized April 2006, 12 days after Omnitrope, for pituitary dwarfism and Turner syndrome; authorization withdrawn voluntarily “for commercial reasons” in October 2011, and withdrawn formally in May 2012.
    • Sandoz: Omnitrope® marketed in EU, where it was authorized April 2006 for pituitary dwarfism, Prader-Willi syndrome, and Turner syndrome; the first biosimilar authorized by the European Medicines Agency. In U.K., was the first biosimilar recommended for approval by the National Institute for Health and Clinical Excellence in 2010. In Japan, launched October 2009 as that nation’s first approved biosimilar

    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.

  • Herceptin (trastuzumab)

    Drug developers:

    • Amgen, Synthon, and Watson (now Actavis): Global licensing agreement announced July 18, 2012, for clinical development and testing of biosimilar. Deal followed publication March 2, 2012, of Phase I trial results showing bioequivalence between Synthon’s biosimilar and Herceptin
    • BioXpress: Biosimilar in active development
    • Hanwha Chemical: Biosimilar in development. Hanwha has said it is seeking a partner to commercialize Herceptin and HD203, a biosimilar for Enbrel
    • Hospira: Biosimilar in active development.
    • Pfizer: PF-05280014 completed Phase I REFLECTIONS B327-01 trial as of December 2012, to study the safety and pharmacokinetics of the biosimilar compared to Herceptin. The study yielded “positive data,” hence the company “is exploring plans to go into Phase III this year, Mikael Dolsten, president of Pfizer’s Worldwide Research & Development unit, said on the Q4 2012 earnings conference call January 29.
    • PlantForm: Clinical trials in humans expected to begin in 2014. Biosimilar expected to be launched, “in partnership with a pharmaceutical company,” in world markets in 2016
    • Stada Arzneimittel: Joined with Gedeon Richter in announcing plans August 2011 to collaborate on biosimilars for trastuzumab and rituximab. Richter agreed to buy from Stada trastuzumab for a “low single-digit million Euros figure,” they announce.

    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.


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