Nine block­buster drugs to watch are mak­ing their de­but, aim­ing at a $16B prize in 2021

The bio­phar­ma in­dus­try is front-load­ing block­buster drug ap­provals this year.

Clar­i­vate An­a­lyt­ics list­ed the 9 block­busters their an­a­lysts ex­pect to see ap­proved by the FDA this year, and on­ly 4 of them have yet to get the green light in ear­ly Q2, in­clud­ing No­vo Nordisk’s semaglu­tide, their GLP-1 drug for di­a­betes, and As­traZeneca’s PD-L1 check­point dur­val­um­ab.

It’s a new world in the pay­er com­mu­ni­ty, and the con­sen­sus peak sales pro­jec­tions seem to be fur­ther off the mark than ever as the com­mer­cial kick­back grows steadi­ly worse. But it is al­ways in­ter­est­ing to see what an­a­lysts be­lieve the big new drugs of the year are go­ing to be worth 5 years down the road.

In this case, as out­lined in the Drugs to Watch re­port, the to­tal is $16 bil­lion in an­nu­al rev­enue.


Top of the mark: Ocre­vus, the new MS drug from Roche with an es­ti­mat­ed rev­enue stream of $3.3 bil­lion in 2021. Right be­hind comes Dupix­ent, the stel­lar eczema break­through from Re­gen­eron and Sanofi, which is ex­pect­ed to hit $2.8 bil­lion.

Mer­ck KGaA makes the list — prob­a­bly for the first le­git­i­mate block­buster thumbs up in more than a decade — for their check­point avelum­ab, part­nered with Pfiz­er and now ap­proved to be sold as Baven­cio. They have the num­ber 4 check­point on the mar­ket, with As­traZeneca now poised to get 5th place.

But Clar­i­vate has As­traZeneca beat­ing out the more ad­vanced ri­val, pre­sum­ably cred­it­ing their shot at a com­bo ap­proach with the in-house CT­LA-4 check­point treme­li­mum­ab. In­creas­ing­ly, though, an­a­lysts are won­der­ing if PD-L1 and CT­LA-4 are such a good match, con­sid­er­ing the tox pro­file.

So re­mem­ber, these are just es­ti­mates. And 2021 is a long, long way away.

As usu­al, the phar­ma gi­ants dom­i­nate the list, but biotech is clear­ly play­ing a big role in the lead-up to com­mer­cial­iza­tion. Tesaro — the new PARP play­er — makes the list along with Re­gen­eron’s stand­out an­ti­body team. And this year In­cyte gets in­to the block­buster lane, with Eli Lil­ly, on the im­pres­sive baric­i­tinib, which is look­ing at a loom­ing PDU­FA date. Kite just bare­ly falls short of block­buster sta­tus on this list with its pi­o­neer­ing and new­ly filed CAR-T, but some­thing tells me they’ll give this one an ex­tra push to see if they can break the mark ear­li­er.

Lists rarely repli­cate each oth­er. Eval­u­atePhar­ma put to­geth­er their list of top drugs in the pipeline, and came up with 15 prospec­tive block­busters. Ei­ther way you look at it, though, it’s go­ing to be a bet­ter year than 2016, when the FDA record­ed OKs on on­ly 22 new drugs.

Check out their re­port, which al­so looks at the way sales are pro­ject­ed to build over the next 5 years. We’ll be keep­ing score.


Im­age: Shut­ter­stock

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

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We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Can­cer as­so­ci­a­tion says na­tion­al bud­get deal threat­ens re­search fund­ing

As the US House of Representatives is expected to vote this evening on a deal that would raise the nation’s debt ceiling, some biopharma industry advocates worry about how proposed budget restrictions could affect drug research.

The proposed budget deal includes relatively flat funding for non-defense spending over the next fiscal year, and a 1% increase in fiscal year 2025, which the Association for Clinical Oncology said on Wednesday would “considerably restrict potential resources for the National Institutes of Health (NIH) and National Cancer Institute (NCI) at a time when scientists are on the cusp of so many promising cancer discoveries.”

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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Ky­owa Kirin re­news sup­port for foun­da­tion that ful­fills wish­es for ter­mi­nal­ly ill adults

Although not as well-known as the pediatric-focused Make-A-Wish organization, the Dream Foundation has been making wishes come true for adults diagnosed with a terminal illness for decades. Kyowa Kirin began supporting the group six years ago, and now is doubling down on its commitment and extending its pledge through next year.

The financial support of Kyowa Kirin and on-the-ground work by its employees have directly led to 100 final dreams for people across the US and Puerto Rico. The Dream Foundation overall grants 2,500 requests each year to people who have a prognosis of 12 months or less to live. The wishes fulfilled range from family trips to places such as Disneyland or beach destinations to professional sports games to meet a sports hero.

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San­doz plans to stay lo­cal af­ter No­var­tis sep­a­ra­tion, se­lect­ing new HQ in Basel

Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus.

The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024.

Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.”

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Patients reveal their personal cancer perspectives in Amgen's unscripted video series. (Amgen Oncology)

Am­gen cen­ters can­cer pa­tients’ voic­es in new YouTube se­ries

In Amgen’s new oncology video series, patient Gina calls her colorectal cancer diagnosis “the best worst thing that’s ever happened to me.” She goes on to talk about her Stage IV diagnosis and initial, terminal prognosis four years ago, but also describes her strong family support system and a group created by her husband around a healing star theme.

Gina is one of seven “Patient Points of View” in Amgen Oncology’s new YouTube series, debuting today, and an example of the personal, forthright and unscripted perspectives each person offers. The unbranded campaign includes people with non-small cell lung cancer, small cell lung cancer and gastric cancer as well. Amgen’s goal is to “give them the microphone” to tell their stories for self-empowerment, but also for employees and others who can learn from them, said Michelle Carrillo, executive director of advocacy at Amgen. Several of the videos include Amgen researchers who talk about their work and hopes for creating transformative medicines.

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