Brensocatib

iStock, PeterHermesFurian Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void? Despite receiving European approval for inflammatory lung disease drug Brinsupri last November, Insmed is holding off on launching the product due to lingering questions around President Donald Trump’s Most Favored Nation drug pricing initiative. The company is far from the only biopharma reevaluating their global launch strategies in light of MFN. As the far-reaching effects of the policy unfold, experts warn that retreating from overseas markets could have unintended consequences—including providing a springboard for Chinese biotechs. In addition to Insmed, Ligand Pharmaceuticals, United Therapeutics and multiple other companies have discussed how MFN is shaping their ex-U.S. strategies. Many other drugmakers are evaluating their strategies in private. Matthew Majewski, vice president at Charles River Associates (CRA), told BioSpace that companies working in various therapeutic areas have asked his team whether they should be launching in the EU and other MFN reference markets. Companies have questioned whether they can limit launches to the markets where they can charge the most to avoid eroding U.S. prices, Majewski explained. However, that approach has a flaw. As Eva Marchese, vice president at CRA, told BioSpace , a new EU pharma regulatory package contains provisions to stop companies from cherry-picking EU countries. Without the package, a drugmaker could limit launches to countries such as Germany. With the package, the U.S. price could be tied to the Czech Republic and Spain. A CMS assessment found Germany’s purchasing power is 83% of that of the U.S., while in the Czech Republic and Spain it is 64%. Drug pricing Despite MFN Deals, Drug Pricing Will Dog Pharma Into 2026 Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo. January 6, 2026 · 5 min read · Annalee Armstrong Read more If the Trump administration pushes ahead with its proposed MFN models, drugmakers will need to either accept lower prices in the U.S., persuade reference countries in the EU and other regions to pay more or restrict where they launch medicines. Majewski described the situation as a “game of chicken.” Unless someone backs down, Majewski said some drugs might not reach the EU in “the short-ish term.” Nerea Blanqué-Catalina, a partner in global market access, pricing and sustainability at Alira Health, agreed, even going so far as to suggest that drug availability in the U.S. and Europe could diverge to the extent that there are effectively two different standards of care. The situation has led experts to start considering what happens if companies avoid launching drugs in Europe or set high prices that severely limit uptake. One possibility is that Chinese biotechs will fill the gap. Filling the Void Typically, multiple companies are developing molecules for every major drug target. If one company decides against launching in the EU, a rival that is less price-sensitive could quickly introduce a molecule with the same mechanism of action. Allistair Booth, a partner at Pinsent Masons, told BioSpace via email that Chinese biotechs “are very well placed to take advantage of any market anomalies MFN creates.” Booth estimated that the cost of drug development in China may be low enough to enable commercially viable returns on ex-U.S. products. Majewski said biopharma companies are “saber-rattling” about the threat of Chinese biotechs claiming markets abandoned by U.S.-focused drugmakers over MFN concerns. Yet he agrees that companies from China, Europe or other regions could step up if new drug launches are restricted to the U.S. Opinion The High Stakes Tradeoffs of a Most Favored Nation Drug Policy President Donald Trump loves a deal, but Most Favored Nation drug pricing isn’t a good one for anyone. August 13, 2025 · 3 min read · Fred Roeder Read more The consequences of rivals claiming overseas markets could come back to the U.S. market. If a company can set a price that is acceptable to EU payers, Majewski sees no barrier to them bringing the product to the U.S. and undercutting companies that have avoided MFN reference markets. Citing that scenario, Majewski predicted that companies with drugs that can be copied will conclude that they need to launch in the EU despite MFN dictating that U.S. prices must drop as a result. For now, though, experts who spoke with BioSpace maintain that, in the near term, a U.S.-only strategy is likely to win out. Blanqué-Catalina foresees MFN limiting which drugs launch in the EU for at least the next five years. Concern about reputational risk could slow the divergence, as drugmakers headquartered in Europe would feel “very weird” to only launch a medicine in the U.S., Marchese said. However, such pressures only apply to a subset of the top global drugmakers. Majewski agreed that for now, European patients will miss out on novel therapeutics. “U.S. prices need to come down, and European prices need to come up a little bit in order to meet this happy medium. There could be some pain while we play this game,” Majewski said. “Long term, there’s hope for the future that we’ll figure it out.” .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! Market insights, trending business and policy stories for biopharma leaders hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "7c139b3c-ff0b-44e0-bffe-f449801dca59", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } });

Insmed has presented results from a trial of its lung disease antibiotic Arikayce, which could lead to a label expansion that would increase its addressable patient population from 30,000 to 200,000. On top of the newly approved lung disorder pill Brinsupri, which Insmed expects will achieve blockbuster sales this year, the New Jersey company has revealed results from a trial of its older lung disease treatment, Arikayce, which could pave the way for a significant label expansion.The phase 3b Encore study tested inhaled Arikayce plus the antibiotic combination of azithromycin and ethambutol versus placebo added to the antibiotic duo in newly diagnosed patients with Mycobacterium avium complex (MAC) lung infection.The trial met its primary and multiplicity-controlled secondary culture conversion endpoints, the company said in a March 23 release. The Arikayce regimen showed both statistically significant and clinically meaningful improvements in respiratory symptom score (RSS) and culture conversion rates. With the results, Insmed plans to file for a label expansion in the second half of this year, which would allow its use in newly diagnosed patients who have not received antibiotics. Arikayce was initially approved by the FDA for refractory disease back in 2018.An expansion would increase Arikayce’s addressable patient population from 30,000 to a major 200,000, Insmed CEO William Lewis said in a Monday conference call. He added that the company expects the results—which fulfill the FDA’s post-marketing requirement—will also convince the agency to convert Arikayce’s nod from accelerated to full. “This is a particularly difficult disease to treat,” Lewis said. “Every other company that has come along trying to bring forward a medicine has failed to be able to produce clinical trial results in a double-blind study that are adequate for approval. I think that just highlights the desperate need for this patient population.”The results triggered a 7% increase in Insmed’s share price on Monday morning.As for the primary endpoint, patients in the Arikayce arm after 13 months gained an average of 17.8 points from baseline on the RSS scale, compared to a 14.7 average increase in the placebo group. The key secondary endpoints were sputum culture conversion rates measured at a variety of timeframes. After 13 months, a statistically significant proportion of Arikayce patients achieved culture conversion, 82% versus 56%. After 15 months, a statistically significant proportion of Arikayce patients achieved durable culture conversion, 76% compared to 48% in the control arm. Similar culture conversion rates were evident (PDF) at every measured time period from month one to month 15. Lewis said the results are “striking” evidence of Arikayce's ability to improve outcomes for MAC patients earlier in their treatment journey. He compared results from Insmed’s previous trial of the treatment, which showed culture conversion in roughly a third of patients.“What is important to note here is that the data from this study is unequivocally positive from the perspective of physicians who are seeking to eradicate evidence of the infection in their patient populations,” Lewis said. “There is a powerful motivation in the data to move to treat these patients earlier and the dropout rate going down suggests that the treatment burden for the patient is reduced.” The active component of antibiotic Arikayce is amikacin, a two-decade-old antibiotic that was originally administered intravenously until Insmed created its inhaled formulation to treat MAC, which is a potentially fatal condition and has been diagnosed in more patients in Japan than in the U.S.In 2025, sales of Arikayce were up 19%, reaching $434 million. Lewis said the company would reveal later how the potential expansion would impact its peak sales.