An­gry Pfiz­er ac­cus­es J&J of vi­o­lat­ing an­titrust laws in safe­guard­ing a megablock­buster fran­chise

John Young

By most ac­counts, Pfiz­er was on the verge of in­flict­ing some se­ri­ous pain on J&J’s fran­chise drug Rem­i­cade when it rolled out a biosim­i­lar of the megablock­buster drug in the US last year. But the com­pe­ti­tion from knock­offs bare­ly dent­ed sales, and now Pfiz­er is claim­ing in a fed­er­al law­suit that its Big Phar­ma ri­val owes its suc­cess to mo­nop­o­lis­tic sales prac­tices.

Pfiz­er is tack­ling J&J in the US Dis­trict Court for the East­ern Dis­trict of Penn­syl­va­nia, where it al­leges that its phar­ma ri­val em­ployed “ex­clu­sion­ary con­tracts and oth­er an­ti­com­pet­i­tive prac­tices (which) have de­nied U.S. pa­tients ac­cess to ther­a­peu­tic op­tions and un­der­mined the ben­e­fits of ro­bust price com­pe­ti­tion in the in­no­v­a­tive and grow­ing bi­o­log­ics mar­ket­place for pa­tients,” ac­cord­ing to a state­ment from the com­pa­ny.

Pfiz­er is claim­ing that J&J vi­o­lat­ed fed­er­al laws along the way, in­clud­ing an­titrust pro­vi­sions. The law­suit states:

The threat from In­flec­tra did not go un­no­ticed by J&J. With­in weeks of In­flec­tra’s launch, J&J be­gan to de­ploy what it pub­licly terms its “Biosim­i­lar Readi­ness Plan.” The core fea­tures of the plan are ex­clu­sion­ary con­tracts that fore­close Pfiz­er’s ac­cess to an over­whelm­ing share of con­sumers, cou­pled with an­ti­com­pet­i­tive bundling and co­er­cive re­bate poli­cies de­signed to block both in­sur­ers from re­im­burs­ing, and hos­pi­tals and clin­ics from pur­chas­ing, In­flec­tra and oth­er biosim­i­lars of Rem­i­cade de­spite their low­er pric­ing.

J&J, though, has al­ready shrugged off any near-term hit from biosim­i­lar com­pe­ti­tion, and ex­ecs say they have some big ad­van­tages in main­tain­ing their fran­chise rev­enue.

J&J CFO Do­minic Caru­so re­cent­ly told at­ten­dees at a con­fer­ence that the small dis­count of­fered by Pfiz­er as well as the lack of in­ter­change­abil­i­ty with the main­stay is blunt­ing the ri­val’s abil­i­ty to carve away mar­ket share.

Pfiz­er, though, begs to dif­fer on that score. And the case will be close­ly fol­lowed by all the big play­ers in the in­dus­try — from those de­vel­op­ing biosim­i­lars of some of the biggest block­busters now on the mar­ket to the com­pa­nies that are afraid of the gener­ic com­pe­ti­tion that is loom­ing.

“By of­fer­ing high­ly sim­i­lar ther­a­peu­tic op­tions for pa­tients, doc­tors and health plans, biosim­i­lars fos­ter ther­a­peu­tic choice and in­creased ac­cess to bi­o­log­ic med­i­cines around the world,” said John Young, Pfiz­er’s group pres­i­dent of its Es­sen­tial Health di­vi­sion. “For U.S. pa­tients and providers to re­al­ize the ben­e­fits of biosim­i­lars, new and ex­ist­ing biosim­i­lar en­trants should have a fair chance to com­pete with orig­i­na­tor prod­ucts – now and in the fu­ture – based on law­ful pric­ing and ac­cess prac­tices. By sup­port­ing the avail­abil­i­ty of biosim­i­lar ther­a­pies, we can help en­sure that pa­tients have bet­ter ac­cess to a wide range of low­er cost ther­a­peu­tic op­tions.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

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The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

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In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Roche un­veils three new mon­key­pox tests as cas­es rise

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.

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Last week, plaintiff Elliot Conrad Dale — who’s paid for GSK’s Ventolin and Arnuity Ellipta inhalers — filed a class-action lawsuit against the pharma giant, accusing it of scheming to block generic versions of its brand-name inhalers.