Wegovy Knockoff Sparks Big Pharma Clash

Wegovy injectable pen and its packaging on a wooden surface
BIG PHARMA CLASH

Hims & Hers undercuts President Trump’s Wegovy pricing deal with a cheap $49 knockoff pill, prompting Novo Nordisk to vow legal action over safety risks and illegal compounding.

Story Snapshot

  • Novo Nordisk launched oral Wegovy last month under Trump administration pricing, only for Hims to copy it immediately at $49/month—$100 cheaper.
  • Novo labels Hims’ version an “unapproved, inauthentic knockoff” that endangers patients through illegal mass compounding.
  • Compounding exploits legal loopholes post-shortage, threatening FDA-approved drugs and intellectual property in the booming GLP-1 market.
  • Stocks plunge: Novo and Eli Lilly down over 6%, Hims hit by litigation threats.

Hims Launches Compounded Wegovy Copy

Hims & Hers Health announced its compounded oral semaglutide pill, using Wegovy’s active ingredient. Priced at $49 for the first month, it undercuts Novo Nordisk’s oral Wegovy by $100, arranged via a Trump administration deal to make obesity treatments accessible.

Hims claims a different formulation protects the ingredient during digestion and offers personalized dosing. This move targets the surging demand for GLP-1 drugs, with the market projected to reach 100 million prescriptions.

Novo Nordisk Fires Back with Legal Threats

Novo Nordisk immediately condemned Hims’ product as “illegal mass compounding and deceptive advertising.” Spokesperson Ambre James-Brown stated that it poses a “significant risk to patient safety” because it is an untested knockoff with potential impurities.

Unlike FDA-approved Wegovy, the compounded version has not undergone rigorous testing. Novo vows to take legal and regulatory action to protect intellectual property and ensure that only authentic drugs reach patients seeking obesity relief.

Experts like UBS analyst Michael Yee note compounded oral semaglutide has unclear absorption and side effects due to formulation differences. While compounders serve about 1 million prescriptions versus 100 million for branded drugs, they erode Novo’s market share.

This follows Novo’s launching of oral Wegovy last month, the fastest pharmaceutical rollout by prescription totals, to counter Eli Lilly’s gains.

Background of Compounding Loopholes

GLP-1 drugs like semaglutide exploded in demand for obesity, causing shortages that allowed compounding under U.S. law Sections 503A/B for individual patients. Compounders continued to dispense personalized doses after the shortage, despite FDA warnings and lawsuits.

Hims previously faced FDA scrutiny for deceptive GLP-1 advertising. Novo this week forecasted a decline in 2026 sales growth due to such competition, wiping out tens of billions in market value.

The FDA enforces compounding laws but prioritizes the safety of branded drugs. Hims leverages telehealth for mass access, but Novo holds regulatory and IP advantages.

Eli Lilly shares fell by more than 6% after the announcement, highlighting industry-wide pressure. Patients gain cheaper options but risk untested compounds, fueling debates on access versus safety.

Market and Patient Impacts

Short-term, stocks tumbled: Novo and Lilly down more than 6%, Hims significantly post-threat. Long-term, these challenges Novo’s oral Wegovy momentum and sustain compounder battles.

Obesity patients weigh affordable access against safety concerns like impurities and dosing issues. The clash underscores tensions in the GLP-1 sector, with potential FDA crackdowns ahead as Lilly eyes oral approvals.

Conservatives cheer Trump’s pricing deal, making Wegovy affordable without Big Pharma gouging, yet worry knockoffs undermine innovation and safety that protect American families from unproven drugs. This corporate skirmish tests limited government oversight of FDA standards versus free-market access.

Sources:

BioPharma Dive: Hims launches compounded Wegovy rival, drawing Novo legal threat

MedWatch: Novo Nordisk threatens action against Hims & Hers compounded semaglutide

Business Insider: Novo Nordisk issues statement on illegal mass compounding by Hims & Hers

Pharmaphorum: Hims & Hers copies Novo Nordisk’s new Wegovy pill