Anticipated shortage of Merck’s fertility drug ‘Gonal-F’

Merck anticipates a supply shortage starting from the 15th and expects to return to normal after April 30th

Manufacturing 300/450/900IU is delayed, but 150IU can be used as a substitute drug

Merck has announced that 300/450/900IU Gonal-F Pen are expected to be short in supply.

 

The shortage of Merck’s 'Gonal-F Pen,' which is the world’s first recombinant follicle stimulating hormone (r-FSH), is expected.

 

Merck has announced that three, 300/450/900IU, of the four volumes of Gonal-F Pen approved by the Ministry of Food and Drug Safety (MFDS) are expected to be short in supply.

 

Currently, the 150IU volume is in stock.

 

Gonal-F, a medication for treating infertility, was approved in South Korea in 2007, following approvals in Europe in 1995 and the United States in 1997.

 

It is used in 100 countries worldwide.

 

Due to temporary supply delays stemming from manufacturing plant schedule, domestic supply shortages are expected from the 15th.

 

“We are taking all necessary measures to ensure a smooth supply of our products.

 

Once production at the manufacturing plant resumes, domestic supply is expected to return to normal after April 30th,” Merck stated.

 

Gonal-F is a self-injectable medication used in female fertility procedures to induce follicular maturation and ovulation.

 

Produced using the FBM (Filled-by-mass) method, it reduces batch-to-batch variability from 20% in other infertility treatments to 2%.

 

It is primarily used for anovulation disorders, such as polycystic ovary disease (PCOD), and for ovarian stimulation and ovulation induction in assisted reproductive technology (ART).

 

The Gonal-F prefilled pen form simplifies self-injection by providing clear dosage and administration information, reducing the burden of self-injection with a quick administration time of approximately 5 seconds.

 

In 2020, Gonal-F imports totaled approximately KRW 10 billion when combining the sales of three dosages: 300IU at $1,473,768, 450IU at $915,755, and 900IU at $5,002,681, according to the import performance data from the MFDS.

 

“Treatments can be substituted with Gonal-F 150IU or recombinant human follicle-stimulating hormone (FSH), which is currently approved and marketed,” Merck stated, anticipating that the supply disruption would have a minimal impact.

 

Besides Gonal-F Pen, another medicine that contains the active ingredient follitropin alpha is Yooyoung Pharm’s 'Bemfola Prefilled Pen,' which had an import report of $1,517,095 in 2022.

 

Additionally, Merck’s FDA-approved 'Pergoveris' is available.

 

Pergoveris contains the active ingredients follitropin alpha, recombinant human follicle-stimulating hormone (r-hFSH), and lutropin alfa, recombinant human luteinizing hormone (r-hLH).

 

Pergoveris can be used to treat severe infertility in patients who have deficiencies in both follicle-stimulating hormone and luteinizing hormone.