Nearly 13 years after Congress created a biosimilars path to bring competition to the U.S. biologics market, new rules of the road are coming into play, via the Inflation Reduction Act (IRA), that could change the course for biosimilars in the long haul – if the IRA’s prescription price negotiation mandate withstands several constitutional challenges. In mapping out the biosimilars route, Congress balanced the need for innovation with the necessity of keeping drug prices in check by providing 12 years of exclusivity for the innovator. But patents, not the regulatory exclusivity, have created a bottleneck for biosimilars. The IRA could change that by incentivizing the manufacturers of the biggest blockbuster biologics to license biosimilars, allowing them to launch by the time the innovator’s 12-year exclusivity ends, or shortly thereafter. On the other hand, it could extend those monopolies by reducing biologic prices to a level that discourages competition.

Argenx CIDP win in phase II yields $1.1B financing arrangement

On the heels of positive top-line data from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy, Argenx SE priced a global public offering of $1.1 billion. The Amsterdam-based firm is selling about 1.5 million American depositary shares (ADS) for $490 each and 663,918 ordinary shares for €436.37 (US$488.17) each in the deal, expected to close July 24. Every ADS represents the right to receive one ordinary share, with a nominal value of €0.10 each. Argenx targeted $750 million when the financing was launched. The company’s stock (NASDAQ:ARGX) was trading midday at $529.47, up $22.95.

US federal agencies propose to limit mergers that would create ‘a clog on competition’

The U.S. Federal Trade Commission and the Department of Justice have floated a new set of guidelines that would govern their reviews of mergers in a variety of markets, including the drug and device industries. While many of these guidelines are vaguely worded and open to interpretation, one of the more ambiguously worded passages states that a merger may be rejected if it could create “a clog on competition,” a phrase that appears in a Supreme Court decision handed down more than 60 years ago.

Prestige Biopharma aims to become leading cancer drug developer 

Prestige Biopharma Ltd. is mounting efforts to rise rank through the industry with a two-pronged strategy of becoming a global cancer antibody drug developer and contract development and manufacturing organization. On July 18, the Biopolis, Singapore-headquartered company announced it would become an official member of the U.S. National Cancer Institute’s Cancer Moonshot – renewed as CancerX – reignited by U.S. President Joe Biden to cut cancer-related deaths by half in 25 years and improve lives of patients across the country. “CancerX will increase support for our core PAUF-based pancreatic cancer treatment through cooperation [with local members] in the U.S.,” Prestige Biopharma CEO Lisa (Soyeon) Park said. “With this newfound opportunity, we will accelerate commercialization of PBP-1510 (ulenistamab), the novel pancreatic cancer antibody drug that earned the FDA’s fast track designation in March.” 

Santen sells North American ophthalmic portfolio to Visiox, Harrow  

Santen Pharmaceutical Co. Ltd. is selling its North American branded ophthalmic portfolio to Visiox Pharma LLC and Harrow Health Inc. in a move to make its global organization as competitive as possible, Santen told BioWorld. To that end, Santen, of Osaka, Japan, signed an out-licensing agreement with Visiox for Omlonti, an eye drop approved in September 2022 for reducing intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Santen also made an asset transfer agreement with Harrow Health under which Harrow will acquire exclusive U.S. and Canadian commercial rights for six U.S. products and two Canadian products.

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