Trastuzumab

ArticlesRefrigerated StorageLactation Safety InformationNew Medicines ·
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Articles

Refrigerated Storage

HerceptinRoche Products Ltd

Roche Products Ltd
Herceptin
600mg solution for Injection in Vial

In the event of an inadvertent temperature excursion the following data may be used:
Once removed from the refrigerator Herceptin subcutaneous formulation must be administered within 6 hours and should not be kept above 30°C.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Storage at ambient temperature: not provided by manufacturer.

Do not freeze. Keep the vial in the outer carton in order to protect from light.

28 September 2020
London MI Service

Herceptin (trastuzumab) Roche Products Limited

Roche Products Limited
Herceptin (trastuzumab)
150mg powder for concentrate for solution for infusion

Contact Roche Products Limited in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Storage at ambient temperature: not provided by manufacturer.

Do not freeze the reconstituted solution.

28 September 2020
London Medicines Information service

HerzumaNapp Pharmaceuticals

Napp Pharmaceuticals
Herzuma
Powder for concentrate for solution, 150mg

In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data from the manufacturers have shown that the unopened vials may be kept up to 25°C for 6 months, or up to 40°C for 3 months.

In-house stability data from the manufacturers for 150mg strength have shown that the unopened vials can be kept for 6 months at 2-8°C after exposure to stress/cycling stability conditions (a total of 12 days at temperatures cycling between -20 ± 5°C and 40 ± 2°C).

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce to 6 months from the date of exposure if stored up to 25°C or 3 months from the date of exposure if stored up to 40°C. Reduce to 6 months from the date of exposure if stored less than 2°C.
Yes
14 May 2020
London MI Service

Herzuma Napp Pharmaceuticals

Napp Pharmaceuticals
Herzuma
Powder for concentrate for solution, 420mg

In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data from the manufacturers for the 420mg strength have shown that the unopened vials may be kept at up to 25°C for 6 months, or up to 40°C for 3 months.

In-house stability data from the manufacturers for 420mg strength have also shown that the unopened vials can be kept up to -20 ± 5° C for 4 weeks.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Reduce to 6 months from the date of exposure if stored up to 25°C or 3 months from the date of exposure if stored up to 40°C. For the 420mg strength reduce to 4 weeks from the date of exposure if stored less than 2°C.
Information not provided by the company
23 June 2020
London Medicines Information Service

Lactation Safety Information

No published evidence of safety
Serious adverse effects reported in adults
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract. However, the effects on the infant of even small amounts in breast milk are unknown
16 September 2020

New Medicines

ZercepacHER2-positive breast cancer and metastatic HER2 positive gastroesophageal cancer

Information

Zercepac
Biosimilar
Accord Healthcare
Henlius

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
September 2020
Sep 20Launched in the UK [7].
Aug 20Zercepac licensed (EPAR on EMEA website) [6].
May 20Recommended for EU approval by CHMP - the full indications include metastatic and early breast cancer and metastatic gastric cancer as for the originator product [5].
Jun 19Henlius announces that the EMA has accepted for review the MAA for trastuzumab biosimilar HLX02 [1].

Category

Anti-HER2 monoclonal antibody
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2/100,000 and the mortality 23.1/100,000 [2]
HER2-positive breast cancer and metastatic HER2 positive gastroesophageal cancer
Intravenous infusion

Trial or other data

Nov 19HLX02 achieved similar overall response rate to reference trastuzumab in women with HER2+ recurrent or previously untreated metastatic breast cancer, according to a large, randomised phase III study to be reported at the ESMO Asia Congress 2019 [4].
Jun 19PIII trial NCT03084237 comparing HLX02 with Herceptin ongoing, recruiting completed [3].

Evidence based evaluations

trastuzumab biosimilar (EG12014)HER2-positive breast cancer

Information

trastuzumab biosimilar (EG12014)
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Anti-HER2 monoclonal antibody
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2/100,000 and the mortality 23.1/100,000 [2]
HER2-positive breast cancer
Intravenous infusion

TuznueHER2-positive breast cancer and gastric or gastroesophageal junction adenocarcinoma in adults

Information

Tuznue
Biosimilar
Napp
Prestige BioPharma

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials
Jun 20Napp will not launch Tuznue in the UK as it already has an exclusive distribution agreement with another manufacturer of trastuzumab for this market [5].
Jul 19Napp (part of the Mundipharma group of companies) have not yet decided whether they will market Tuznue in the UK, they already have a trastuzumab biosimilar Herzuma [4].
Jul 19Mundipharma has entered into an exclusive license and supply agreement with Prestige Biopharma for Tuznue, a trastuzumab biosimilar treatment.The agreement will enable the Mundipharma network to distribute, market and sell Tuznue in selected European countries following marketing authorization (unclear from article whether this includes UK) [3].
May 19EMA has validated and accepted for review the Marketing Authorization Application (MAA) for trastuzumab biosimilar HD201 [1].

Category

Anti-HER2 monoclonal antibody
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2/100,000 and the mortality 23.1/100,000. [2]
HER2-positive breast cancer and gastric or gastroesophageal junction adenocarcinoma in adults
Intravenous infusion

Trial or other data

OgivriMetastatic and early breast cancer and gastric cancer

Information

Ogivri
Biosimilar
Mylan - Biocon
Mylan - Biocon

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Dec 19Launched in the US for all indications of Herceptin including treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Final price has not been released but will be at a "competitive discount" to Herceptin [12].
Dec 18Approved in the EU [11].
Oct 18Mylan N.V. and Biocon Ltd. announce that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri [9].
Oct 18The proposed EU licence includes treatment of metastatic and early breast cancer and metastatic gastric cancer [10].
Dec 17Approved in US and resubmission accepted in the EU [7,8].
Sep 17Approval in the US has been delayed by 3 months. The FDA have extended the target action date from Sept to Dec 2017 to allow time to review some clarificatory information, apparently not related to any GMP audit observations at the manufacturing facilities. The delay is not expected to affect the predicted launch date. Meanwhile in the EU, filing has been withdrawn while the manufacturing issues are addressed, and a resubmission is anticipated next quarter [6].
Jul 17Mylan and Biocon, who had expected to be first to market with a trastuzumab biosimilar in Europe, have hit a stumbling block that could delay their bid. The EMA found issues with its product plant in Bangalore and has told them a follow-up inspection will be required to ensure changes are implemented before the EMA will grant approval. Inspectors noted nearly 36 deficiencies, 11 of them major, ranging from management of out of spec results, to cross contamination risks [4].
Jul 17The FDA’s Oncologic Drugs Advisory Committee voted 16-0 in favour of Mylan’s proposed trastuzumab biosimilar to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease. The agency can´t approve the biosimilar in metastatic gastric cancer until Herceptin´s orphan exclusivity in that indication runs out in October [5].
Nov 16Filed in US to treat certain HER2-positive breast and gastric cancers [2].
Aug 16Filed in EU [1].

Category

Biosimilar monoclonal antibody - HER2 inhibitor
Around 17% of gastric cancers are HER-2 positive (NICE TA208 costing template 2010)
Metastatic and early breast cancer and gastric cancer
Intravenous

Trial or other data

Dec 16NCT02472964 published in JAMA. PIII RCT (n=500) showed Myl1401O resulted in equivalent overall response rate at 24 weeks compared with originator trastuzumab (69.6% vs 64%, respectively). Further study is needed to assess safety and long-term clinical outcome [3].
Aug 16PIII data was presented earlier this year at the American Society of Clinical Oncology meeting and showed Myl1401O achieved the same overall response level as Herceptin after 24 weeks of therapy [1].

Evidence based evaluations