With at least six others behind it, Amgen Inc.’s Amjevita is leading a 2023 U.S. biosimilars charge to challenge the all-time biggest-selling drug, Humira (adalimumab), from Abbvie Inc. Amjevita hit the U.S. market Jan. 31, and Amgen has the biosimilar priced at two levels. One is a list price 55% below Humira’s list price of about $115,000 annually and the second is 5% below Humira’s list price. Boehringer Ingelheim GmbH, Sandoz Inc., Samsung Bioepis Co. Ltd./Organon & Co., Pfizer Inc., Viatris Inc. and Coherus Biosciences Inc. all have biosimilar challengers to Humira that are set to launch in July 2023, all likely to come with a lower price tag than Humira’s.

US Third Circuit hands biopharma big 340B win

Neither the courts nor the Department of Health and Human Services (HHS) get to fill in the gaps in the law that created the 340B prescription drug discount program, the U.S. Court of Appeals for the Third Circuit said, as it ruled that HHS’ efforts to enforce its interpretation of the statute are unlawful. According to the department’s interpretation, biopharma companies must provide the prescription drug discounts “wherever and to whomever a buyer demands,” Judge Stephanos Bibas wrote in the unanimous opinion handed down yesterday in Sanofi Aventis U.S. LLC v. HHS. “But the relevant law says nothing about such duties,” the judge continued. The ruling is a big win for drug companies that have placed restrictions on the 340B discounts to contract pharmacies.

CS Pharma gains Chinese rights to Daewoong’s antifibrotic agent, bersiporocin, in $336M deal 

Daewoong Pharmaceutical Ltd. has out-licensed greater China rights for its idiopathic pulmonary fibrosis (IPF) candidate, bersiporocin (DWN-2088), to CS Pharmaceuticals Ltd. in a deal worth up to $336 million. Under the terms, Daewoong granted CSP exclusive development and commercialization rights to bersiporocin in IPF and other respiratory indications in mainland China, Hong Kong, Taiwan and Macau. In exchange, Daewoong will receive $76 million in up-front fees and up to $336 million in development milestone payments and double-digit sales royalties. Bersiporocin is a prolyl-tRNA synthetase inhibitor being developed by Daewoong for IPF and potentially other fibrotic indications.

China’s Alpha Biopharma seeks new drug status for EGFR-TKI product 

Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer (NSCLC) with central nervous system (CNS) metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company. Zorifertinib targets sensitive EGFR mutations (exon 19 deletion and exon 21 L858R). Widely expressed in human epidermal and stromal cells, EGFR also is highly expressed in various human malignancies, such as NSCLC. EGFR gene mutations can accelerate the abnormal growth and division of cells, eventually leading to tumorigenesis. CNS metastases are common in EGFR-mutated NSCLC patients.

Newco news: Clinical trial on horizon for company that restores the adipocyte 

After raising an undisclosed sum in a series A round, French biotech company Adipopharma LLC aims to progress its make-or-break targeted insulin resistance peptide into a phase I trial in type 2 diabetes patients by the end of 2023. Peptide of Apkc Targeting AlmS (PATAS) targets the protein ALMS1 in the adipocyte, as it does so restoring glucose absorption in diseased cells, and so has promise in directly treating insulin resistance, rather than tackling the consequences of type 2 diabetes, such as glycemia and cardiovascular complications, as currently available medications do.

Biden administration to allow pandemic-driven public health emergency to end 

The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the FDA’s ability to issue emergency use authorizations will not be immediately affected as that authority was invoked by a separate mechanism.

The BioWorld Insider Podcast: Rethinking obesity – Fitness may be more directly linked to health than weight

After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity.

Also in the news

Abbisko, Aeolian, Alpha, Ammax, Apic, Aptose, Arecor, Boehringer Ingelheim, C4, Carsgen, Coeptis, Curevac, Daiichi, Eisai, Eli Lilly, Equilibre, Escient, FSD, Hillstream, Huidagene, Inovio, Junshi, Kancera, Matinas, MD Andersen, Moderna, Nanoscope, NFL, Novelmed, Quince, Regeneron, Roche, Sandoz, Tonix, Uniqure, Vera, X-Chem, Xeris, Ymmunobio, Zai Lab