Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

New Jersey-based Teligent reported a low quarter as the company continues to focus on remediation measures to lift the FDA warning letter hanging over its Buena New Jersey manufacturing facilty. Teligent has also recently recalled a batch of its 4% lidocaine hydrochloride topical solution because the firm’s testing found it to be super potent.

India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.

South Korea’s Celltrion has delivered a strong second quarter on the back of high-margin US sales, as its Truxima rituximab biosimilar recovered. The company is on track to launch at least one biosimilar every year by 2030. Meanwhile, the company and partner Icure have filed a donepezil patch with the Korean Ministry of Food and Drug Safety.

Japanese player Towa Pharmaceutical joined Sawai in capitalizing on Nichi-Iko’s misery by taking market share from its rival, as it ran factories at full capacity and plotted for further expansion.

Sawai was strong in Japan and weak in the US in the first financial quarter of its 2022 financial year, as analysts called on the Japanese firm to improve supply capacity as a “crucial first step towards expanding market share.”

Stada saw a small drop in both sales and profitability for its Generics division, but insisted the firm’s “strong position in generics,” alongside its leading position in consumer healthcare and growing specialty offering, “put the group on a sustainable growth course.”

Adcock Ingram enjoyed a rise in sales but a dip in profit during its 2020/21 financial year, as the South African firm laid out plans to launch 20 products during its current financial year ending in June 2022, including 18 generics and one new chemical entity.

With five “large, durable assets” in its pipeline, Lannett is confident that post approval these products have the potential to transform the company. This includes the generic version of Boehringer Ingelheim’s Spiriva Handihaler (tiotropium bromide) recently added to Lannett’s respiratory generics portfolio.