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May 19, 2014

Biosimilars: 11 Drugs to Watch

If imitation is the sincerest form of flattery, these innovator drugs should be blushing.

Biosimilars: 11 Drugs to Watch

This year we turn the list up to 11, as the biosimilar market is booming. [© Sebastian Kaulitzki - Fotolia.com]

  • Herceptin (trastuzumab)

    Drug developers:

    • Amgen: Biosimilar in development, with pivotal trial launched in 2013, the company stated in a letter to shareholders accompanying its Form 10-K for last year. The biosimilar is one of four for oncology indications that Amgen is developing in collaboration with Actavis.
    • Biocad: Biosimilar in late-stage clinical study
    • Biocon-Mylan: CanMab marketed in India; launched October 23, 2013, after Roche ended patent litigation against the companies
    • BioXpress Therapeutics: Biosimilar in pipeline
    • Celltrion: Herzuma set for launch in South Korea following approval by authorities
    • Hanwha Chemical: HD201 in Phase I study in Europe as of 2013. Hanwha has said it is seeking a partner to commercialize HD201 and HD203, a biosimilar for Enbrel
    • Hospira: Biosimilar, under license from Celltrion, expected to be submitted for marketing approval to European Medicines Agency later this year, following April 10 court decision by Justice Colin Birss invalidating patents related to the composition and dosages of trastuzumab
    • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.
    • Pfizer: PF-05280014 in Phase III development for metastatic breast cancer, the company confirmed in its May 8, 2014, pipeline update. Seven days earlier, the company disclosed on ClinicalTrials.gov that it was recruiting patients for the study, named REFLECTIONS B327-02 and designed to assess the biosimilar plus Paclitaxel in HER2 positive first line metastatic breast cancer treatment (NCT01989676).
    • 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; 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.

  • 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 development, company stated in its Form 10-K for 2013
    • BioXpress Therapeutics: Biosimilar in pipeline; development partnership announced October 25, 2012, with AET BioTech, the separate biosimilars business within the generic drug developer AET (Alfred E Tiefenbacher) Group, under which AET BioTech and BioXpress said they will be jointly responsible for the development, registration, and manufacture of the biosimilar
    • Boehringer Ingelheim: BI695501 is the subject of a Phase I clinical study (NCT02045979) assessing the biosimilar’s safety and pharmacokinetics compared to Humira (adalimumab); the study is ongoing but not recruiting participants, the company disclosed April 30 on ClinicalTrials.gov. A similar study was completed in New Zealand last year.
    • Fujifilm and Kyowa Hakko Kirin: Companies announced a 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.
    • Momenta: M923 predicted to be a biosimilar for either Humira or Enbrel;4 company has not confirmed which, but has said it plans a regulatory filing later this year. M923 is company’s lead biosimilar program.
    • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.

    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

  • Neulasta (pegfilgrastim)

    Drug developers:

    • 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
    • Sandoz: Two Phase III studies completed last year: PROTECT1, which compared the efficacy and safety of branded Neulasta with LA-EP2006 (NCT01735175); and PROTECT2, which compared the efficacy and safety of the biosimilar to LA-EP2006 (NCT01516736). Both studies measured the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
    • Teva: Company withdrew application for Balugrastim (formerly Neugranin) in November 2013, citing ongoing consultation with the FDA. Launch delayed in 2011, when company reached settlement of litigation with Amgen in which it agreed not to sell Neugranin until November 2013 unless it first obtained a final court decision that Amgen patents were not infringed by the biosimilar.

    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.

  • Neupogen (filgrastim)

    Drug developers:

    • Apotex: Grastofil marketed in EU, where it was authorized October 18, 2013, for neutropenia
    • 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 as of 2012; 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 2013 for a noninterventional, long-term safety data collection of the biosimilar and Filgrastim Hexal in stem cell donors, according to ClinicalTrials.gov (NCT01766934)
    • Stada Arzneimittel: Grastofil, inlicensed from Apotex, set for a 2014 launch after winning approval in October 2013 from the European Commission for the treatment of neutropenia in adults
    • 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

    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

  • Remicade (infliximab)

    Drug developers:

    • Amgen: Biosimilar in active development, company stated in its Form 10-K for 2013
    • BioXpress Therapeutics: Biosimilar in pipeline
    • Celltrion: Ramsima (formerly CT-P13) marketed in South Korea, having won approval in July 2012 as the first Remicade biosimilar to be approved in the world. Indicated for rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and psoriasis. Applied for marketing authorization in EU.
    • Hospira: Inflectra marketed in EU and other markets, including the U.S., under license from Celltrion for rheumatoid arthritis (RA), ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis psoriatic arthritis and psoriasis; European launch followed approval September 2013 by the European Commission. First monoclonal antibody to be approved through the European Medicines Agency’s biosimilars regulatory pathway.
    • Ranbaxy Laboratories and Epirus Biopharmaceuticals: BOW015 to be developed and supplied by Epirus under license agreement with Ranbaxy, which upon regulatory approval will market the product in India and other unnamed “emerging markets,” the companies announced January 9, 2014

    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)

    Drug developers:

    • Amgen: Biosimilar in development, with pivotal trial launched in 2013, the company stated in a letter to shareholders accompanying its Form 10-K for last year. The biosimilar is one of four for oncology indications that Amgen is developing in collaboration with Actavis.
    • Biocad: AcellBia registered in Russia; first monoclonal antibody biosimilar to receive a positive opinion from regulators. Agreement signed last year for export of rituximab APIs produced by Biocad and Kocak Farma
    • BioXpress Therapeutics: Biosimilar in pipeline
    • Boehringer Ingelheim: BI695500 in three trials recruiting patients as of April 30, according to ClinicalTrials.gov: A Phase III study assessing efficacy, pharmacokinetics, and safety of the biosimilar in patients with rheumatoid arthritis (NCT01682512); a Phase III study assessing the safety and efficacy of the biosimilar in patients with moderately to severely active rheumatoid arthritis (NCT01955733); and a Phase I study assessing the pharmacokinetics and pharmacodynamics of BI 695500 vs. rituximab as first-line treatment in patients with low-tumor-burden lymphoma (NCT01950273)
    • 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: Biosimilar in Phase I development. Company says its iBioLaunch platform, a gene expression technology that causes nontransgenic plants to rapidly produce high levels of target proteins, addresses several multibillion dollar markets including “biosimilars/bio-betters.” Announced October 5, 2011 that it produces rituximab in nontransgenic green plants.
    • Intas Biopharmaceuticals: MabTas marketed in India following launch February 26, 2013
    • Merck: MK-8808 the subject of U.S. clinical trials NCT01390441 and NCT01370694, both of which are active but not recruiting as of April 16 and May 1, respectively, the company disclosed on ClinicalTrials.gov
    • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.
    • Pfizer: PF-05280586 in Phase I development for rheumatoid arthritis, the company confirmed in its May 8, 2014, pipeline update. Two trials ongoing but not recruiting participants, REFLECTIONS B327-01, a Phase I/II pharmacokinetic/pharmacodynamic study which compares the biosimilar to rituxumab in subjects with active rheumatoid arthritis with an inadequate response To TNF inhibitors (NCT01526057); and -06, an extension trial for patients who have participated in other PF-05280586 trials (NCT01643928)
    • Probiomed: Kikuzubam marketed in Bolivia, Chile, Mexico, and Peru
    • Roche: CEO Severin Schwan was quoted in March 2013 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.
    • 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.
    • Sandoz: GP2013 in two clinical trials now recruiting patients: Phase III ASSIST_FL study assessing biosimilar in treatment of patients with previously untreated Advanced Stage Follicular Lymphoma (NCT01419665), the company told ClinicalTrials.gov on April 10, 2014; and a Phase I study in Japanese patients with CD20-positive low tumor burden indolent B-cell non-Hodgkin’s lymphoma (NCT01933516), according to the trial’s most recent update on August 28, 2013 
    • 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”
    • Teva and Lonza: On July 25, 2013, announce they will end four-year-old joint venture to develop, manufacture, and market biosimilar drugs, more than three months after Lonza issues a statement denying it will end the joint venture in response to its CEO, Richard Ridinger, telling the Swiss newspaper Finanz und Wirtschaft it was reviewing whether to continue the effort.
    • Zenotech Laboratories: Biosimilar marketed in India following launch February 27, 2013

    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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