Date: 2018-10-18

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: Ogivri® - Zedora® - MYL-1401O

Compound: trastuzumab-dkst - biosimilar version of trastuzumab

Therapeutic area: Cancer - Oncology

Action mechanism:

  • biosimilar/monoclonal antibody. MYL-1401O is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers.
  • Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.
  • Mylan has exclusive commercialization rights for the biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.
  • Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Company: Mylan (USA - PA) Biocon (India) Libbs Farmaceutica (Brazil)

Disease: HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, HER2-positive advanced gastric cancer

Latest news:

  • • On October 18, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Ogivri®, a biosimilar to Roche's Herceptin® (trastuzumab). This biosimilar drug is intended for the treatment of HER2 positive breast and gastric cancer. Ogivri® will be available as a 150-mg powder for concentrate for solution for infusion. This biosimilar product  is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
  • -as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments
  • -in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable
  • -in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
  • -in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
  • Ogivri® is also indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):
  • -following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)
  • -following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel
  • -in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
  • -in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri® therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.
  • Ogivri® in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Ogivri® should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
  •     • On December 29, 2017, the biosimilar trastuzumab, co-developed by Biocon and Mylan, has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company. This is the first biosimilar trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora®, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil .
  • Biocon and Mylan are responsible for the development of biosimilar trastuzumab. While currently the trastuzumab will be manufactured by Biocon and supplied to Libbs for commercialization in Brazil ; over a period of time the technology will be transferred to Libbs and the public partner Butantan through a Productive Development Partnership (PDP). Libbs have already built the biotechnological site to manufacture Zedora® for the Brazilian market.
  • • On December 1, 2017, Mylan and Biocon  announced that the FDA has approved Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon . Ogivri ™ has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
  • Ogivri™ is the first FDA -approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the U.S. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin®, as a result of Mylan's ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan's biosimilar to Herceptin in various markets globally.
  • FDA approval was based on robust data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared Ogivri™ to Herceptin®. The data demonstrated that Ogivri™ is highly similar to Herceptin® and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. The FDA's decision follows the unanimous vote by the FDA Oncologic Drugs Advisory Committee (ODAC) in July 2017 recommending approval of Mylan's biosimilar to Herceptin®.
  • In the U.S. , an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone. Approximately 20% to 25% of primary breast cancers are HER2-positive. Herceptin® had U.S. sales of more than $2 billion for the 12 months ending Sept. 30, 2017 , according to IQVIA.
  • • On August 3, 2017, Mylan officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ogivri®, for the treatment of breast cancer and gastric cancer. The application was withdrawn after the CHMP had evaluated the documentation provided byMylan and formulated lists of questions. The company had not responded to the last round of questions at the time of the withdrawal.
  • Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ogivri® could not have been approved for the treatment of breast cancer and gastric cancer. The CHMP’s main concern was the lack of a valid certificate confirming that the manufacturing facility of the product complies with good manufacturing practice (GMP) requirements. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough documentation to support the application for Ogivri®.
  • In its letter notifying the Agency of the withdrawal of the application, Mylan stated that it was withdrawing the application because a GMP certificate for the manufacturing site of the product could not be obtained in the time available.
  • • On November 8, 2016, Mylan and Biocon announced submission of Mylan’s biologics license application (BLA) for MYL-1401O to the FDA through the 351(K) pathway. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S. The submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data. The clinical data consists of two pharmacokinetic studies and the HERITAGE confirmatory efficacy and safety trial. The results of the HERITAGE trial were presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress.


Submission of marketing authorization application USA : 2016-11-08

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE: 2017-08-03

US authorization: 2017-12-01

UE authorization:

Favourable opinion UE: 2018-10-18

Favourable opinion USA: 2017-07-13

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes