You are here

Home » Industry » Prescription medicines » Regulatory decisions and notices » Australian prescription medicine decision summaries

Ovaleap

18 March 2021

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New biosimilar medicine
Product name
Ovaleap
Active ingredients
Follitropin alfa
ATC codes
G03GA05
Decision
Approved
Date of decision
9 March 2021
Date of entry onto ARTG
10 March 2021
Original publication date
18 March 2021
ARTG numbers
328120, 328121, 328122
Black Triangle Scheme
No
Sponsor
Theramex Australia Pty Ltd
Sponsor address
60 Margaret Street, Sydney NSW 2000
Dose forms
Solution for injection
Strength
300 IU/0.5 mL, 450 IU/0.75 mL and 900 IU/1.5 mL
Other ingredients
Monobasic sodium phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride and water for injections
Containers
Cartridge (fill volumes; 0.5 mL, 0.75 mL, 1.5 mL)
Pack sizes
One cartridge
Routes of administration
Subcutaneous injection
Dosage

Treatment with Ovaleap should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.

The injection site should be alternated daily to prevent lipoatrophy. Self-administration of Ovaleap should only be performed by patients who are well motivated, adequately trained and who have access to expert advice. Ovaleap cartridge should only be administered using the Ovaleap Pen, which is separately available.

The recommended dosage of Ovaleap depends on multiple factors, including the condition being treated and the individual patient's response to treatment.

For further information refer to the Product Information.
Pregnancy category

D

Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.

What was approved?

Ovaleap (follitropin alfa) was approved for the following therapeutic use:

  1. The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.
  2. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.
  3. Ovaleap is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • Post marketing reports are to be prepared annually until the period covered by such reports is not less than three years from the date of the approval letter. No fewer than three annual reports are to be prepared. The reports are to at least meet the requirements for periodic safety update reports (PSURs) as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII Periodic Safety Update Report (Rev 1), Part VII.B. Structures and processes. Reports are to be submitted to the TGA only when requested in writing by the TGA. When requested, reports must be provided to the TGA within ten (10) calendar days. Preparation of the report must be completed within ninety calendar days of the data lock point for that report. An annual report may be made up of two PSURs each covering six months. Note that submission of a PSUR does not constitute an application to vary the registration.
  • Laboratory testing and compliance with Certified Product Details
    • All batches of:
      • Ovaleap 450 IU/0.75 mL follitropin alfa (rch) solution for injection- cartridge;
      • Ovaleap 900 IU/1.5 mL follitropin alfa (rch) solution for injection- cartridge;
      • Ovaleap 300 IU/0.5 mL follitropin alfa (rch) solution for injection- cartridge

      supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).

    • When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
  • Certified Product Details

    The CPD, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.

  • For all injectable products the Product Information must be included with the product as a package insert

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.