Competition intensifies in Forsteo market with 4 latecomers

Rapid market reorganization observed after first follow-on biosimilar enters market in 10 years

Pharmbio Korea receives approval for Forsteo’s biosimilar… limitations in reimbursement that covers only second-line or subsequent lines of treatment criticized

Fourth biosimilar to enter market after Dong-A ST, Daewon Pharm, BMI Korea…receives mixed expectations in market

Teriparatide products Fosteo and Teribone

Products with the same ingredient as the world’s first bone anabolic agent 'Forsteo(Teriparatide),' which was finally able to receive reimbursement in Korea 10 years after its approval, are rapidly entering the market.

 

Domestic pharmaceutical companies are occupying the follow-on market with their Forsteo latecomers.

 

Already 4 teriparatide products have entered the market.

 

On the 16th, the MFDS approved Pharmbio Korea’s teriparatide biosimilar.

 

The product contains the same teriparatide ingredient as Forster and is indicated for the treatment of osteoporosis in women and men.

 

The drug was approved as a biosimilar after demonstrating its bioequivalence to Forsteo.

 

Forsteo is Lilly Korea’s osteoporosis treatment that was approved in 2002.

 

As the first bone anabolic(bone-forming) agent, Forsteo received much attention for its different treatment mechanism from existing antiresorptive agents.

 

Previous bone resorption inhibitors had inhibited the release of calcium from the bone into the bloodstream, however, Forsteo, as an anabolic agent, promoted proliferation and activity of osteoblasts that are involved in new bone formation.

 

It took 10 years for the drug after being approved in 2006 to receive reimbursement.

 

Forsteo was approved for reimbursement as second-line treatment in 2016.

 

However, patients who showed no effect or are unable to use one or more of the existing bone resorption inhibitors are allowed reimbursement for Forsteo.

 

Since receiving reimbursement, Forsteo defeated the then-leading bisphosphonate products in the market and become the top leader in the market.

 

Domestic pharmaceutical companies quickly followed on its course with their biosimilars.

 

Dong-A ST was the first to be approved for its more convenient, single, once-weekly injection formulation of the same ingredient, ‘Teribone subcutaneous inj.’ in 2015.

 

In 2019, Daewon Pharm was the first to be approved for Forsteo’s biosimilar, ‘Terrosa Cartridge.’ And last year, BMI Korea was approved for Teribone’s biosimilar, ‘Teria inj,’ sparking full competition in the market.

 

And the recent introduction of PharmBio’s second Forsteo biosimilar increases the count of teriparatide products to 4.

 

Based on IQVIA, Forsteo sold ₩17.1 billion, Teribone ₩2 billion, Terossa ₩0.8 billion last year.

 

Forsteo continued to show strength as the original by ranking second in the osteoporosis treatment market, but the latecomers still have a long way to catch up due to their late entry.

 

However, this does not mean that Forsteo’s has a solid lead over its competitors because of the large gap between Forsteo and the market leader 'Prolia (₩75.1 billion).' Prolia is a biologic bone resorption inhibitor that is administered once every 6 months and is considered to have upgraded the effect and convenience in administration over existing osteoporosis treatments.

 

In particular, Prolia’s reimbursement was extended to first-line from April 2019, showing an advantage over Forsteo in market competitiveness as it is still only reimbursed in the second-line.

 

This is why there are some negative outlooks on the market performance of Forsteo latecomers.

 

However, there is also analysis that the drugs will show strength in the market if reimbursement is expanded to first-line.