After years of underfunding, stigmatization and lack of research, companies working on products and services that address women’s health care are gaining traction. But the sector also faces unique challenges, such as gaining approval for ads on major social media platforms.

FDA officials question whether modeling tools can predict which drugs have different disposition in obese populations. They say physiologically-based pharmacokinetic data cannot be used as a surrogate for actual clinical trial data at this time.

Organon CEO Kevin Ali has acknowledged that the long-term future for the biosimilars business is unclear, despite the firm’s biosimilars segment currently acting as a solid growth driver for the company.

Organon CEO Kevin Ali has suggested that discounts for US Humira biosimilars could “range anywhere between 80% and 90%” by 2025-2026, amid a slew of competition on adalimumab starting within weeks.