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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]

  • Humira (Adalimumab)

    Drug developers:

    • AET BioTech and BioXpress: Biosimilar being co-developed under agreement announced October 25, 2012; companies will be jointly responsible for development, registration, and manufacture of the biosimilar, based on BioXpress technology. AET BioTech will provide further investment in the biosimilar based on committed long-term financing, and oversee any future commercialization of the product.
    • Amgen: Biosimilar in active development
    • Boehringer Ingelheim: BI695501 completed Phase I trial in New Zealand, studying the biosimilar’s safety and pharmacokinetics compared to Humira (adalimumab) in October 2012.
    • Fujifilm and Kyowa Hakko Kirin: Companies announce 50–50 joint venture, Fujifilm Kyowa Kirin Biologics, to develop a biosimilar version of Adalimumab for rheumatoid arthritis. The venture is proceeding with preparations to begin clinical trials in Europe in the first half of 2013, the companies said October 24, 2012.

    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

  • Neulasta (pegfilgrastim)

    Drug developers:

    • Hospira: Biosimilar in development.
    • Merck & Co.: MK-6302 said to be in clinical development as of 2011 for neutropenia caused by cancer chemotherapy; no further announcement since then on ‘6302, acquired through acquisition of Insmed in 2009
    • Teva: Neugranin launch delayed in 2011, when company reached settlement of litigation with Amgen in which it agreed not to sell Neugranin until November 10, 2013 unless it first obtains a final court decision that Amgen patents are not infringed by the biosimilar.
    • Teva: Lipefilgrastin (XM22) meets primary endpoint in Phase III clinical trial of reducing the duration of severe neutropenia, in a study designed to evaluate the efficacy and safety of lipegfilgrastim compared to pegfilgrastim, the company said June 6, 2011.

    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.

  • Neupogen (filgrastim)

    Drug developers:

    • Biocon and Celgene: Nufil marketed in India by Biocon; in active development for EU by joint venture
    • ctArzneimittel: Biograstim® marketed in EU, where it was authorized September 2008 for cancer, hematopoietic stem cell transplantation, and neutropenia
    • Dr. Reddy’s Laboratories: Grafeel marketed in India
    • Hexal: Filgrastim Hexal® marketed in EU, where it was authorized February 2009 for cancer, hematopoietic stem cell transplantation, and neutropenia
    • Hospira: Nivestim™ marketed in EU, where it was authorized June 2010 for cancer, hematopoietic stem cell transplantation, and neutropenia
    • Intas/Apotex: Neukine in Phase III development
    • Merck & Co.: MK-4214 in Phase III clinical development; acquired through acquisition of Insmed in 2009
    • Ratiopharm: Ratiograstim® marketed in EU, where it was authorized September 2009 for cancer, hematopoietic stem cell transplantation, and neutropenia. Authorization withdrawn voluntarily March 2011, followed two months later by formal European Commission withdrawal.
    • Sandoz: Zarzio® marketed in EU, where it was authorized February 2009 for cancer, hematopoietic stem cell transplantation, and neutropenia In U.S., recruiting patients as of January for a noninterventional, long-term safety data collection of the biosimilar and Filgrastim Hexal® in stem cell donors (NCT01766934)
    • Teva: Tevagrastim® marketed in EU, where it was authorized September 2008 for cancer, hematopoietic stem cell transplantation, and neutropenia

    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

  • Remicade (infliximab)

    Drug developers:

    • Amgen: Biosimilar in active development
    • BioXpress: Biosimilar in active development
    • Celltrion: Ramsima™ (formerly CT-P13) authorized for marketing in Korea on July 20, 2012, for rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and psoriasis. Applied for marketing authorization in EU
    • Hospira: Biosimilar in active development.

    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)

    Drug developers:

    • Amgen: Biosimilar in active development
    • BioXpress: Biosimilar in active development
    • Boehringer Ingelheim: BI695500 in Phase III development in U.S., EU, Brazil, Guatemala, Russia, Norway, Ukraine, Argentina, Peru, New Zealand. U.S. study recruiting participants as of April 17, according to ClinicalTrials.gov (NCT01682512)
    • Celltrion and Hospira: Conducting Phase I trial in South Korea of CT-P10 for RA and another Phase I trial for lymphoma.
    • Dr. Reddy’s Laboratory: Reditux® marketed in Bolivia, Chile, India, and Peru
    • iBio: Announces October 5, 2011, that it produces rituximab in nontransgenic green plants. More recent announcements, however, focus on the company’s technologies for developing biosimilar and proprietary drugs. On April 26, 2012, announces results of ongoing tests showing that its immunomodulator molecule lichenase (LicKM) enhances vaccine antigens when produced as fusions to LicKM. iBio said it will offer commercial collaborations and product licenses to the immunomodulator, dubbed iBioModulator™, which last month was awarded U.S. Patent No. 8,404,252. The iBioModulator has been shown in animal models to increase the strength and extend the duration of immune response to a vaccine antigen.
    • Merck: MK8808 in Phase I development for EU, with trial in Belarus
    • Pfizer: PF-05280586 set this year to complete a Phase II trial launched March 2012 comparing the biosimilar to Rituxan/MabThera. “This year, we expect data,” Mikael Dolsten, president of Pfizer’s Worldwide Research & Development unit, said on the Q4 2012 earnings conference call January 29.
    • Probiomed: Kikuzubam® marketed in Bolivia, Chile, Mexico, and Peru
    • Roche: CEO Severin Schwan was quoted in March as pushing back his company’s anticipated launch of a rituximab biosimilar beyond the 2016 date he had earlier cited in The Wall Street Journal, until the end of this decade.
    • Sandoz: GP2013 in Phase I/II trial for rheumatoid arthritis and non-Hodgkin’s lymphoma, and a Phase III trial for advanced folicular lymphoma. As of last year, the biosimilar was in Phase II trials in Argentina, Austria, Brazil, France, Germany, India, Italy, Spain, and Turkey.
    • Stada Arzneimittel: Joined with Gedeon Richter in announcing plans August 2011 to collaborate on biosimilars for rituximab and trastuzumab. Stada receives nonexclusive rights to sell Richter-produced rituximab in Europe and the Commonwealth of Independent States, excluding Russia. In addition to an undisclosed payment to Richter, Stada also agrees to pay Richter based on progress of the development of rituximab to a “low double-digit million Euros”

    Recently discontinued efforts:

    • Teva and Lonza: End planned 544-patient, Phase III clinical trial of TLO11, saying they wanted input from regulators on designing the trial program (October 2012). On April 5, Lonza issues statement denying news reports that it will end its biosimilar joint venture with Teva4
    • Samsung Biologics: Venture between Samsung and Quintiles halts development of SAIT101, in October 2012, reportedly due to uncertainty over biosimilar regulation in the U.S.

    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:

    • Avastin (Bevacizumab): Amgen is developing a biosimilar to the breast cancer drug, while Fujifilm and Kyowa Hakko Kirin on October 24, 2012, announce 50–50 joint venture, Fujifilm Kyowa Kirin Biologics, to develop a biosimilar version of Avastin (Roche / Genentech) for cancer indications
    • Lispro: Biocon and Mylan announed a strategic collaboration February 14 to develop a biosimilar to the generic version of insulin analog Humalog (Eli Lilly)
    • Glargine: Biocon and Mylan on February 14 announced a strategic collaboration to develop a biosimilar to the insulin analog Lantus (Sanofi)

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