Biocon arm Syngene eyes late-stage clinical supplies amid regulatory shift

As regulators ease biosimilar trial norms, Syngene International is expanding into late-stage clinical supply production, betting on biologics and peptide manufacturing for growth

As international regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) plan to ease frameworks for biosimilar clinical trials, Biocon arm Syngene International Limited is seizing the opportunity to scale up, moving from clinical batch manufacturing to late-stage clinical supply production.

 

Positioned to deepen its presence in high-end biologics and peptide manufacturing, the company views the evolving biotech landscape—shaped by recovering funding, supportive regulations, and shifting global supply chains—as a pivotal moment for expansion.

 

What is Syngene’s strategy for scaling up in biologics and peptides?

 

Clinical batch manufacturing focuses on producing small quantities of drug substance or drug product to support clinical trials, where flexibility, speed, and compliance with good manufacturing practice (GMP) standards are critical. Syngene offers both GMP and non-GMP clinical batch manufacturing capabilities.

 

“The macro market for peptides is among the fastest-growing in the biopharma segment, and that is where Syngene has always had strong capabilities,” said Deepak Jain, chief financial officer, Syngene International. “The growth driven by GLP-based therapies is significant. We are moving from clinical batch manufacturing to late-stage clinical supplies—the next phase of investment that aligns with where the market is heading. Our goal is to expand capacity in step with the industry’s evolution.”

 

How could FDA’s draft guidelines boost India’s biotech sector?

 

The FDA’s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars—lower-priced, near-replicas of complex biologic medicines—could significantly benefit Indian biotech firms. The framework, which proposes limiting human clinical trials for certain biosimilars to make biologic therapies more affordable, is expected to provide a major boost to companies such as Biocon, Dr Reddy’s Laboratories, and Intas that have heavily invested in this segment.

 

“This progressive step will accelerate patient access to safe, effective, and affordable biologic therapies for cancer, diabetes, and other chronic diseases while also helping reduce development costs,” Shreehas Tambe, Managing Director of Biocon Biologics, told Business Standard earlier.

 

Where is Syngene expanding its biologics manufacturing footprint?

 

Syngene highlighted that two major biologics manufacturing sites are becoming operational—one in Bengaluru, which is already producing clinical batches, and another in Bayview, US, slated to go live in the second half of the year. “The impact of these facilities will be felt in FY26, setting us up for stronger growth in the years ahead,” Jain said.

 

On Wednesday, Syngene announced its second-quarter results for FY26 and mentioned the expansion of its clinical trial execution capabilities in five new countries—Australia, New Zealand, the UK, Sri Lanka, and Eastern Europe. This move will help secure its first global Phase 3 trial contract.

 

How is Syngene investing in its next growth phase?

 

On the investment front, Syngene reiterated its FY26 capital expenditure guidance of $45 million for its Indian operations and an additional $10 million for the Bayview facility. While the company did not share a detailed biologics investment breakdown, Jain emphasised that it maintains a strong balance sheet to fund future expansion.

 

Looking ahead, as Syngene deepens its focus on high-end biologics and peptide manufacturing, it sees the evolving biotech environment—driven by funding recovery, regulatory tailwinds, and geopolitical supply chain shifts—as both a challenge and an opportunity.

 

“We are investing ahead of the curve. These are long-cycle businesses, and the groundwork we are laying today will start translating into revenue and profitability growth over the next few years,” Jain said.

 

What do Syngene’s latest results indicate about short-term challenges?

 

Syngene’s quarterly results reflected near-term pressures. The company reported a 2 per cent year-on-year rise and a 6 per cent increase in first-half revenue for FY26, while profitability was affected by a one-time inventory adjustment from a key biologics partner.

 

“Our revenue trajectory remains in line with expectations. We had called out at the beginning of the year that an inventory adjustment from a biologics partner would play out, and that is exactly what we are seeing,” Jain said. The company has maintained its EBITDA guidance in the mid-20s range.