Biocon：保持步伐，未改赛局；YesinteK自动注射器获批提升便利性，而非市场份额

研报英文原文证据摘录

STEIN FLASHMAIL

18 August 2026

Nandan Kulkarni

India Healthcare

Biocon Ltd

Shirsh Sawarna

Rating

Underperform

Price Target

BIOS.IN

326.00 INR

Biocon: Keeping Pace, Not Changing the Race; Yesintek

Autoinjector Approval Improves Convenience, Not Market Share

On 18 August, Biocon announced U.S. FDA approval of supplemental presentations for Yesintek (ustekinumab), adding 45 mg/0.5

mL and 90 mg/mL single-dose prefilled autoinjectors. We view the approval as modestly positive, providing a short-term boost

to a franchise that is already plateauing in a market increasingly dominated by PBM-driven private label brands. Given Yesintek's

broad formulary positioning and the fact that >90% of maintenance patients already self-administer at home, we strongly believe

that autoinjectors do not open a meaningful new channel; rather, it should improve convenience, adherence and patient

retention, particularly in IBD indication. We estimate the device could contribute roughly US$10-15Mn of annualized sales,

primarily through incremental share capture and retention rather than market expansion. However, the competitive advantage is

likely to prove short-lived. Wezlana and Pyzchiva already offer autoinjectors presentations, while Celltrion and Alvotech

are expected to narrow the device gap over the next 8-12 months. More importantly, we believe the longer-term outlook for

the ustekinumab class is degrowing faster than street’s estimates due to growing clinical and commercial momentum of

selective IL-23 therapies such as Skyrizi and Tremfya, which continue to gain share across key indications. We therefore view

today's approval as an important competitive catch-up that strengthens Yesintek's positioning within ustekinumab, but one that is

unlikely to materially alter Biocon's medium-term growth trajectory nor the challenges in its execution blueprint. We maintain our

Underperform rating on Biocon.

EXPECTED CHANGE TO CONSENSUS EARNINGS

>-10%

-7%

-5%

-3%

No Change

+3%

+5%

+7%

>+10%

Yesintek® is Biocon's Biosimilar to J&J's Stelara®, and originally approved by the FDA in November 2024 and launched in the U.S. in

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