Why we need to low­er U.S. reg­u­la­to­ry bar­ri­ers around biosim­i­lar ap­provals now

The FDA’s in­ter­nal re­view on Am­gen’s biosim­i­lar of Hu­mi­ra reads like a prod­uct en­dorse­ment. Post­ed on Fri­day, the agency in­sid­ers es­sen­tial­ly said: Let’s give it a quick kiss on both cheeks and ap­prove this knock­off. It’s good to go on every in­di­ca­tion Ab­b­Vie has in the U.S., which is the lynch­pin to its glob­al, $14 bil­lion fran­chise.

The le­gal war still has to play out, but the re­al les­son here is that now that the ap­pli­ca­tions are com­ing, the agency ex­perts are hav­ing no trou­ble rec­om­mend­ing a green light to these bi­o­log­ic twins. The da­ta pack­ages they’re de­liv­er­ing are de­ci­sive. And years of watch­ing law­mak­ers and reg­u­la­tors play a tug-of-war over the rules around biosim­i­lar de­vel­op­ment have come down to this:

Biosim­i­lars are a per­fect multi­na­tion­al Big Phar­ma play. They build big Phase III stud­ies for prod­ucts they un­der­stand very well. It gives them an en­trée in­to a big mar­ket with low risk, while a high bar­ri­er lim­its com­pe­ti­tion. Even­tu­al­ly, as they crowd in­to the mar­ket, they’ll push dis­counts to the jaw-drop­ping 75%-off lev­els pre­dict­ed re­cent­ly by No­var­tis’ Joe Jimenez, who ought to know.

These are all big steps. But there’s some­thing miss­ing here. Where’s the out­cry from Con­gress for speed­ing up ap­provals?

New can­cer drugs can’t come fast enough, as far as law­mak­ers are con­cerned. Many in Con­gress have said they would give Sarep­ta a hall pass on eteplirsen, on lit­tle to no ev­i­dence of ef­fi­ca­cy. But low risk, cheap­er ver­sions of block­buster drugs? They still face a con­sid­er­able chal­lenge. Why not find ways to low­er some of the reg­u­la­to­ry bar­ri­ers, which were erect­ed as a re­sult of a ve­he­ment in­dus­try lob­by­ing cam­paign?

I’m not say­ing that Con­gress should short­en bi­o­log­ics’ ex­clu­siv­i­ty pe­ri­od. That’s an im­por­tant re­ward that has paid off with a new gen­er­a­tion of bi­o­log­ics and an un­prece­dent­ed lev­el of com­pe­ti­tion in the mar­ket­place – which is what you want to see. But eas­ing reg­u­la­tions would seem to be a per­fect bi­par­ti­san po­si­tion. The rapid ap­proval of a crit­i­cal mass of com­pet­ing bi­o­log­ics would have an im­me­di­ate im­pact on multi­bil­lion-dol­lar fran­chis­es. Busi­ness­es are helped, com­pe­ti­tion is en­cour­aged and prices are low­ered faster.

There are plen­ty of vest­ed in­ter­ests which would like to keep the high bar­ri­er in place. But it’s time to catch up with Eu­rope and change the reg­u­la­to­ry game to fa­vor biosim­i­lars. In ad­di­tion, you’d need to add patent re­form to make it hard­er to pre­vent ri­vals from field­ing biosim­i­lars af­ter the prop­er pro­tec­tion pe­ri­od has come to an end.

In this elec­tion year, that would be a strate­gic con­ces­sion to pop­ulist out­rage over drug prices. It al­so just makes sense.

The time has come.

 

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.