Fresenius Kabi

Fresenius Kabi warned providers to stop using certain Ivenix large-volume pumps due to pneumatic valve issues that could interrupt treatment. The FDA issued an early alert as part of a new pilot program to quickly communicate high-risk recalls. Affected devices should be removed and returned for repair, with no reported injuries or deaths so far.

The USPTO withdrew a proposed rule to add a new requirement for terminal disclaimers to overcome non-statutory double patenting, favoring big pharma over biosimilar developers. The decision was based on 349 comments, with big pharma's outweighing those favoring the change.

Endo, Inc. announced the shipment of doxycycline for injection, USP 100 mg/vial, an AP-rated version of DOXY 100™, strengthening its sterile injectable product portfolio. According to IQVIA®, doxycycline for injection 100 mg vial sales were approximately $49 million for the 12 months ended September 30, 2024.

Formycon AG and MS Pharma enter licensing and supply agreement for FYB202/ustekinumab biosimilar in MENA region. MS Pharma to commercialize and produce FYB202 locally in Saudi Arabia. Formycon retains rights for MENA region after licensing FYB202 globally to Fresenius Kabi in 2023.

Formycon AG and MS Pharma enter licensing and supply agreement for FYB202 (ustekinumab biosimilar) in MENA region. MS Pharma to commercialize and produce FYB202 locally in Saudi Arabia. Formycon retains rights to out-license FYB202 in specific MENA countries. FYB202 approved by FDA and European Commission in September 2024.

Big pharma's patent cliff presents a $200 billion opportunity for biosimilar developers, especially with biologics. Five companies—Alvotech, Biocon Biologics, Celltrion, Formycon, and Samsung Bioepis—are highlighted for their biosimilar developments and partnerships, aiming to capitalize on this market shift. The biosimilar market is projected to grow significantly, reaching $150.26 billion by 2033, driven by FDA regulations and demand for affordable treatments.

Amgen seeks to consolidate four pending BPCIA litigations against biosimilar companies in New Jersey federal court. The MDL Panel issued a briefing schedule on Amgen's motion to transfer, with responses due on December 9. Judge O'Hearn set a trial date for Amgen's case against Celltrion on April 7, 2025.

The generic pharmaceuticals market was valued at USD 424.98 billion in 2024 and is projected to reach USD 874.63 billion by 2033, driven by cost-effective medications, rising chronic disease prevalence, government support, and advancements in manufacturing technologies.

The antibiotics and antimycotics market is projected to reach $91.54 billion by 2031, driven by infectious disease prevalence and R&D initiatives. Key players include Pfizer, Novartis, and Sanofi. North America leads in revenue, with APAC expected to show highest growth.

Formycon reports nine-month results for 2024, highlighting product approvals for FYB202 in the USA and Europe, the start of clinical development for Keytruda® biosimilar FYB206, and the initiation of FYB210 development. Financial results reflect successful business performance, confirming guidance.