Teva Pharmaceutical Industries

The FDA has approved an additional presentation of ustekinumab-aekn (Selarsdi; Alvotech, Teva), expanding its label to include treatment of adults with Crohn disease (CD) and ulcerative colitis (UC). This new 130 mg/26 mL solution in a single-dose vial for intravenous infusion aligns with the reference product's indications and is expected to launch in the US in early 2025.

Teva and Alvotech announce FDA expanded labeling for their biosimilar of J&J's Stelara to include treatment of Crohn's disease and ulcerative colitis.

Alvotech and Teva Pharmaceuticals announce FDA approval of SELARSDI, 130 mg/26 mL solution in a single-dose vial for intravenous infusion, aligning its label with Stelara's indications in the U.S. at launch in Q1 2025.

The FDA approved ustekinumab-aekn (Selarsdi; Teva Pharmaceuticals), a biosimilar to ustekinumab (Stelara), as a 130 mg/26mL solution in a single-dose vial for intravenous use, aligning it with the reference product's indications for a US launch in Q1 2025. Previously, in April 2024, it was approved as a subcutaneous injection for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric individuals 6 years and older.

The FTC's 2023 revised merger guidelines impact pharmaceutical industries with stricter HHI and market share requirements, emphasizing direct evidence of market dominance and ecosystem competition. The FTC scrutinizes pharmaceutical mergers for market concentration, innovation, and entry barriers, with ongoing investigations into Novo Nordisk/Catalent and AbbVie/Cerevel mergers. The EC investigates Zoetis for potential abuse of dominance post-merger, and the FTC challenges fraudulent patents to prevent market monopolization. Pharmaceutical companies are increasingly merging with biotech firms to offset patent expirations and enhance product portfolios.

Novo Nordisk's lawsuit against DCA Pharmacy for selling unapproved Ozempic drugs proceeds. Sanofi and AstraZeneca support Teva's Orange Book defense. FTC supports FDA's biosimilars draft guidance. Par Pharma escapes price-fixing claims via bankruptcy. State AGs request Teva's broader price-fixing case to proceed first.

The global Novel Drug Delivery Systems In Cancer Therapy market size was valued at 16.95 billion in 2023 and is projected to surpass USD 33.34 billion by 2033 with a CAGR of 7% from 2024 to 2033. Market growth is attributed to the adoption of minimally invasive procedures, personalized treatment, precision medicine, and targeted therapies. Technological advancements, increased funding, and rising awareness contribute to market expansion.

The US District Court for the District of New Jersey ordered Teva to delist five inhaler patents from the FDA’s Orange Book, finding they did not claim the drug for which the New Drug Application was submitted. Amneal’s antitrust counterclaims were allowed to proceed as the court rejected Teva’s arguments that the patents were properly listed and that antitrust claims were inapplicable. Teva has appealed the decision to the Federal Circuit, with oral arguments scheduled for November 2024.

Tulisokibart maintained clinical and endoscopic improvements in IBD patients through week 50 in phase II trial extensions, with 48% of ulcerative colitis patients and 56% of Crohn's disease patients achieving clinical remission. The drug was well-tolerated with no identified safety signals.