Viatris and Biocon mull pooling their biosimilars into a $10B standalone company — report

Vi­a­tris (My­lan/Pfiz­er’s Up­john) and In­dia’s Bio­con Bi­o­log­ics are re­port­ed­ly pon­der­ing whether to fur­ther en­twine their biosim­i­lar busi­ness­es in­to a $10 bil­lion stand­alone com­pa­ny, ac­cord­ing to sources from Nisha Pod­dar at an In­di­an af­fil­i­ate of CN­BC.

Ear­li­er this sum­mer, the two com­pa­nies won the first high­ly-cov­et­ed in­ter­change­abil­i­ty des­ig­na­tion for their biosim­i­lar Sem­glee, which is an in­sulin that’s in­ter­change­able with Sanofi’s Lan­tus. Al­though, in a bizarre twist with the way the US in­sulin mar­ket works, the com­pa­nies had to launch two ver­sions of the in­ter­change­able — one at a 65% dis­count, and one at a much high­er price in or­der to gain mar­ket share.

#On CN­BCTV18 | In a large deal brew­ing in the phar­ma sec­tor, sources sug­gest that @Bio­con­lim­it­ed is en­gaged in talks for a large trans­ac­tion to scale up its biosim­i­lar busi­ness and un­lock val­ue. @Pod­dar­Nisha with the de­tails pic.twit­ter.com/phSHrGB­mof

— CN­BC-TV18 (@CN­BCTV18News) De­cem­ber 9, 2021 A Vi­a­tris spokesper­son told End­points News via email, ‘We don’t com­ment on mar­ket ru­mors and spec­u­la­tion.’

Such a deal would bring clos­er to­geth­er two com­pa­nies that are al­ready de­vel­op­ing, man­u­fac­tur­ing and com­mer­cial­iz­ing a port­fo­lio of biosim­i­lars and in­sulin analogs, in­clud­ing biosim­i­lars to Hu­mi­ra, Her­ceptin, Neu­las­ta, and En­brel.

Vi­a­tris, which saw its com­plex gener­ics and biosim­i­lars busi­ness bring in about $1 bil­lion in net sales in the first nine months of 2021, has ex­clu­sive com­mer­cial­iza­tion rights for the biosim­i­lars in the US, Cana­da, Aus­tralia, New Zealand, the EU and Eu­ro­pean Free Trade As­so­ci­a­tion coun­tries. Bio­con Bi­o­log­ics has ex­clu­sive com­mer­cial­iza­tion rights for Japan and cer­tain emerg­ing mar­kets. And they have co-ex­clu­sive com­mer­cial­iza­tion rights in the rest of the world.

In­vest­ment wise, Bern­stein’s biotech an­a­lyst Ron­ny Gal called Vi­a­tris ‘a dis­ap­point­ment’ in an in­vestor note in Ju­ly, not­ing the com­pa­ny has launched mul­ti­ple biosim­i­lars across the US and Eu­rope but ‘the share they are hold­ing is in the sin­gle to low-dou­ble dig­its and price de­clines should most­ly off­set unit gains. There is prob­a­bly room to re­con­sid­er the com­mer­cial strat­e­gy.’

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Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Each year, we aim to highlight 20 extraordinary women who are leaving their mark on drug R&D — and this year’s group was no exception.

Our list, while by no means exhaustive, includes scientists, CEOs, researchers and professors who are supercharging the discovery and development of new therapies worldwide. Our team of writers spent time with each honoree (with a few exceptions), learning their stories and sketching profiles, which you’ll find in our special report.

For the second time, we brought the celebration to a live virtual audience, featuring an award presentation followed by a panel on what it takes to break the glass ceiling in biopharma with Kojin Therapeutics CEO Luba Greenwood, AskBio CEO Sheila Mikhail, and Silverback Therapeutics CEO Laura Shawver. Our panelists had a lively discussion on how the industry’s culture has changed, how to handle sexual harassment, the progress we’ve made and the challenges that still hold women back today.

We applaud each of our honorees for scaling the heights of biopharma R&D. You got to meet most of them via brief recordings we played during our live event. Below, you’ll find bonus videos offering a longer glimpse into those interviews. And if you didn’t get a chance to tune in to our main event live, you can replay the entire show.

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Members of the public disembark a train at King Cross Station in London, on the day that extra measures are put in place to fight the spread of the Omicron variant of Covid-19. Since Nov. 30, it’s been mandatory for people in England to wear face coverings in shops and on public transport. (Ben Cawthra/Sipa USA/Sipa via AP Images)

Like hundreds of other virologists and epidemiologists, Benjamin tenOever’s Thanksgiving weekend was interrupted with emails about an emergency Omicron meeting.

But when he logged onto a WHO conference call 9 a.m. Monday morning, officials had a surprisingly upbeat spin on the little-understood variant that had already prompted leaders around the world, fearful the strain could evade vaccines, to close their borders to broad swaths of Southern Africa.

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The newest building at Fujifilm Irvine Scientific’s Netherlands campus is open for business.

The company, amidst a massive amount of expansion that has placed it in the top-five companies by manufacturing capacity, announced the Tilburg site is fully operational as of Wednesday. It will allow for an increase in efficiency and affordability in shipping, thanks to its central Europe location, as well as put some flexibility into the supply chain.

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Uğur Şahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)

Moderna and Pfizer-BioNTech are now racing to develop Omicron-specific boosters, hoping to be ready if the new immune-evasive variant becomes dominant globally. But it wasn’t always clear that variant boosters could even work.

After the first Covid-19 vaccines were authorized and talk began of variants and next-generation vaccines, several vaccinologists raised concerns in the media and the scientific press about a potentially deleterious phenomenon that sounds as if it were born out of the Vatican’s immunology wing: Original antigenic sin.

The US House of Representatives voted almost unanimously on Wednesday evening (423-3) to pass a bill that will provide $500 million over five years to certain small drugmakers to cover the costs of R&D and to expand access to patients not eligible for clinical trials for potential amyotrophic lateral sclerosis drugs.

Rare neurodegenerative diseases, like ALS, have been historically very difficult to treat and to develop treatments for. But this bipartisan bill, introduced by Rep. Mike Quigley (D-IL) and dozens of cosponsors, will provide $100 million for each of fiscal years 2022 through 2026 to help HHS award grants to facilitate the development and access to ALS drugs intended to prevent, diagnose, mitigate, treat, or cure the disease.

Mathai Mammen, J&J EVP of pharmaceuticals, R&D (Rob Tannenbaum)

The new J&J has a fresh corporate face to show the public — several in fact.

As the healthcare conglomerate follows a now familiar pharma path in separating itself into an innovation-focused R&D-based group from its less appealing consumer side, it’s promoting some key individuals to the executive committee that steers the company.

Those fresh faces include Mathai Mammen, the global head of R&D who joins the inner circle as executive vice president of pharmaceuticals, R&D. External innovation chief Bill Hait becomes executive vice president, chief external innovation, medical safety and global public health officer. Jim Swanson, until today simply the chief information officer, adds the EVP part to his title in moving onto the committee. And Vanessa Broadhurst, company group chairman, global commercial strategy organization, has been appointed EVP, global corporate affairs.

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Square Pharmaceuticals will start production of its $74.36 million factory in Kenya in early 2022, according to The Daily Nation.

The site from the Bangladeshi pharmaceutical leader will produce malaria and diabetes drugs, among other essential medicines. It will manufacture more than 2 billion tablets and capsules a year, enough to make it the largest pharmaceutical manufacturing plant in East and Central Africa. The Kenyan workforce will get technology and training to make the drugs, the company said in a statement Monday.
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